MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00542420

Device Problems Poor Quality Image (1408); Mechanical Jam (2983)

Patient Problems Abdominal Pain (1685); Inflammation (1932); Nausea (1970); Vomiting (2144); Injury (2348); No Code Available (3191)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

Report source: (b)(6) clinical study.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the duodenum on (b)(6) 2020 as part of the (b)(6) clinical study.According to the complainant, during the procedure, the resolution of the exalt scope image was poor when the scope was in motion.Additionally, the clinical site noted that the upward excursion of the exalt scope elevator was limited.Reportedly, the patient was hospitalized on (b)(6) 2020.A peritoneal placement of a pleurx catheter was performed.Miralax was given for narcotic induced constipation.Antiemetics were given as tolerated.Per the clinical site, the adverse event of hospitalization was not related to the image quality problem or elevator problem.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block g3: e7158 exalt dscope 01b clinical study block h6 (patient codes): patient code 1970 captures the reportable event of nausea requiring hospitalization.Patient code 2144 captures the reportable event of vomiting requiring hospitalization.Patient code 1932 captures the reportable event of pancreatitis requiring hospitalization.Patient code 3191 captures the reportable event of hospitalization.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the duodenum on (b)(6) 2020 as part of the exalt d scope 01b clinical study.This complaint is being reported based on the event of hospitalization.According to the complainant, during the procedure, the resolution of the exalt scope image was poor when the scope was in motion.Additionally, the clinical site noted that the upward excursion of the exalt scope elevator was limited.Reportedly, the patient was hospitalized on (b)(6), 2020.A peritoneal placement of a pleurx catheter was performed.Miralax was given for narcotic induced constipation.Antiemetics were given as tolerated.Per the clinical site, the adverse event of hospitalization was not related to the image quality problem or elevator problem.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.***additional information received on (b)(6), 2021*** on (b)(6)2020, the subject had an ercp and 2 stents replaced.The subject was unable to be given intravenous (iv) contrast due to an allergy and was given oral contrast during procedures.At home after the procedure, the subject began to feel nauseous with associated epigastric and right upper quadrant abdominal pain.Reportedly, the subject was also vomiting.The subject presented to the emergency department and managed with iv fluids, and fentanyl.Lovenox was discontinued on (b)(6), 2020 in anticipation of a paracentesis drain to be placed (b)(6), 2020.On (b)(6), 2020, the subject was hemodynamically stable and symptoms were resolved after iv antiemetics and analgesia.Subject received pleurx catheter without complications and aki improved with resuscitation.The subject was discharged in stable condition on (b)(6), 2020.Reportedly the event was considered resolved on (b)(6), 2020.***additional information received on (b)(6) 2021*** reportedly, pleurx was planned in november 2020 due to recurring need for paracentesis.Additionally, the exalt scope was used with a zipwire guidewire during the procedure.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the duodenum on (b)(6) 2020 as part of the exalt d scope 01b clinical study.This complaint is being reported based on the event of hospitalization.According to the complainant, during the procedure, the resolution of the exalt scope image was poor when the scope was in motion.Additionally, the clinical site noted that the upward excursion of the exalt scope elevator was limited.Reportedly, the patient was hospitalized on (b)(6) 2020.A peritoneal placement of a pleurx catheter was performed.Miralax was given for narcotic induced constipation.Antiemetics were given as tolerated.Per the clinical site, the adverse event of hospitalization was not related to the image quality problem or elevator problem.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received on january 5, 2021.On (b)(6) 2020, the subject had an ercp and 2 stents replaced.The subject was unable to be given intravenous (iv) contrast due to an allergy and was given oral contrast during procedures.At home after the procedure, the subject began to feel nauseous with associated epigastric and right upper quadrant abdominal pain.Reportedly, the subject was also vomiting.The subject presented to the emergency department and managed with iv fluids, and fentanyl.Lovenox was discontinued on (b)(6) 2020 in anticipation of a paracentesis drain to be placed (b)(6) 2020.On (b)(6) 2020, the subject was hemodynamically stable and symptoms were resolved after iv antiemetics and analgesia.Subject received pleurx catheter without complications and aki improved with resuscitation.The subject was discharged in stable condition on (b)(6) 2020.Reportedly the event was considered resolved on (b)(6) 2020.Additional information received on january 14, 2021.Reportedly, pleurx was planned in (b)(6) 2020 due to recurring need for paracentesis.Additionally, the exalt scope was used with a zipwire guidewire during the procedure.Additional information received on february 9, 2021.The nausea, vomiting and abdominal pain was determined to be an acute episode that happened to occur post ercp.Labs were not indicative of pancreatitis.

Manufacturer Narrative

Block g3: e7158 exalt dscope 01b clinical study.Block h6 (patient codes): patient code e1020 captures the reportable event of nausea requiring hospitalization.Patient code e1032 captures the reportable event of vomiting requiring hospitalization.Patient code e2326 captures the reportable event of pancreatitis requiring hospitalization.Block h10: the returned exalt model d single-use duodenoscope was analyzed, and a visual evaluation noted that there was no evidence of any damage or defect observed on the shaft or tip of the device.No fogging or condensation was noted on or in the lens.Procedural residue was observed in the distal cap and could be cleared away with an alcohol wipe.A functional evaluation of the elevator was performed and there were no problems found.The elevator performed as expected.An image assessment was performed by connecting the device to an exalt controller.Upon connection, a live image was displayed.No problems were observed with the image.The nausea, vomiting, and pancreatitis are most likely due to the patient conditions and treatment intended to resolve their condition.The risk review and labelling review conducted as part of the investigation confirmed that infection and inflammation is a known risk of the device, and the medical conditions are likely secondary to the treatment of this or due to other conditions the patient has experienced.Based on all available information, the conclusion code selected for this is adverse event related to patient condition.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the duodenum on (b)(6) 2020 as part of the exalt d scope 01b clinical study.According to the complainant, during the procedure, the resolution of the exalt scope image was poor when the scope was in motion.Additionally, the clinical site noted that the upward excursion of the exalt scope elevator was limited.Reportedly, the patient was hospitalized on (b)(6) 2020.A peritoneal placement of a pleurx catheter was performed.Miralax was given for narcotic induced constipation.Antiemetics were given as tolerated.Per the clinical site, the adverse event of hospitalization was not related to the image quality problem or elevator problem.Additional information received on january 5, 2021: on (b)(6) 2020, the subject had an ercp and 2 stents replaced.The subject was unable to be given intravenous (iv) contrast due to an allergy and was given oral contrast during procedures.At home after the procedure, the subject began to feel nauseous with associated epigastric and right upper quadrant abdominal pain.Reportedly, the subject was also vomiting.The subject presented to the emergency department and managed with iv fluids, and fentanyl.Lovenox was discontinued on (b)(6) 2020 in anticipation of a paracentesis drain to be placed (b)(6) 2020.On (b)(6) 2020, the subject was hemodynamically stable and symptoms were resolved after iv antiemetics and analgesia.Subject received pleurx catheter without complications and aki improved with resuscitation.The subject was discharged in stable condition on (b)(6) 2020.Reportedly the event was considered resolved on (b)(6) 2020.Additional information received on january 14, 2021: reportedly, pleurx was planned in (b)(6) 2020 due to recurring need for paracentesis.Additionally, the exalt scope was used with a zipwire guidewire during the procedure.Additional information received on february 9, 2021: the nausea, vomiting and abdominal pain was determined to be an acute episode that happened to occur post ercp.Labs were not indicative of pancreatitis.

Manufacturer Narrative

Block g3: e7158 exalt dscope 01b clinical study.Block h6 (patient codes): patient code e1020 captures the reportable event of nausea requiring hospitalization.Patient code e1032 captures the reportable event of vomiting requiring hospitalization.Patient code e2326 is no longer applicable to this event as the labs were not indicative of pancreatitis.Block h10: the returned exalt model d single-use duodenoscope was analyzed, and a visual evaluation noted that there was no evidence of any damage or defect observed on the shaft or tip of the device.No fogging or condensation was noted on or in the lens.Procedural residue was observed in the distal cap and could be cleared away with an alcohol wipe.A functional evaluation of the elevator was performed and there were no problems found.The elevator performed as expected.An image assessment was performed by connecting the device to an exalt controller.Upon connection, a live image was displayed.No problems were observed with the image.The nausea, vomiting, and pancreatitis are most likely due to the patient conditions and treatment intended to resolve their condition.The risk review and labelling review conducted as part of the investigation confirmed that infection and inflammation is a known risk of the device, and the medical conditions are likely secondary to the treatment of this or due to other conditions the patient has experienced.Based on all available information, the conclusion code selected for this is adverse event related to patient condition.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Block h11: block h6 (patient codes) was corrected to remove code e2326.

• Brand Name: EXALT MODEL D SINGLE-USE DUODENOSCOPE
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11090154
• MDR Text Key: 227880725
• Report Number: 3005099803-2020-06479
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729983514
• UDI-Public: 08714729983514
• Combination Product (y/n): N
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2022
• Device Model Number: M00542420
• Device Catalogue Number: 42420
• Device Lot Number: 0026042272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR