MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER

Model Number M00546780

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Fever (1858); Inflammation (1932); Sepsis (2067)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

(pro code): ntn.Initial reporter address: (b)(6).(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

This report pertains to a spybite and spy discover catheter used during the same procedure.It was reported to boston scientific corporation that a spybite and spy discover catheter were used in the biliary tract during a percutaneous transhepatic cholangiography (ptc) procedure performed on (b)(6) 2021 as part of the e7160 spyglass discover percutaneous study.On (b)(6) 2021, one biliary drainage was implanted into the patient.On (b)(6) 2021, a guidewire assisted spyglass discover digital catheter was advanced to the biliary stricture and the target lesions or stones were visualized with a spyglass digital system.A spybite max biopsy forceps was also used during the study.A biopsy of the biliary stricture of lesion was completed and an intraductal drain remained in place at the end of the procedure.On (b)(6) 2022, the patient experienced moderate haemobilia and treated with an antibiotic and saline solution.The treatment was resolved and stopped on (b)(6) 2022.The haemobilia was not related to the spy discover scope in the investigation site's assessment.On (b)(6) 2022, an unscheduled intervention occurred for biliary drainage dislodge.The patient required an additional pcts procedure conducted by an interventional radiologist as an inpatient placing a drain.On (b)(6) 2022, the patient developed fever and dyspnea due to the appearance of a hepatic collection.Drainage of the collection was performed, and antibiotics plus two blood transfusions were given.It was reported that a hepatic embolization was performed on the patient the day after the study procedure.On (b)(6) 2022, it was indicated that patient discharge was pending.

Event Description

Note: this report pertains to a spybite and spy discover catheter used during the same procedure.It was reported to boston scientific corporation that a spybite and spy discover catheter were used in the biliary tract during a percutaneous transhepatic cholangiography (ptc) procedure performed on december 30, 2021 as part of the e7160 spyglass discover percutaneous study.On (b)(6) 2021, one biliary drainage was implanted into the patient.On december 30, 2021, a guidewire assisted spyglass discover digital catheter was advanced to the biliary stricture and the target lesions or stones were visualized with a spyglass digital system.A spybite max biopsy forceps was also used during the study.A biopsy of the biliary stricture of lesion was completed and an intraductal drain remained in place at the end of the procedure.On (b)(6) 2022, the patient experienced moderate haemobilia and treated with an antibiotic and saline solution.The treatment was resolved and stopped on january 9, 2022.The haemobilia was not related to the spy discover scope in the investigation site's assessment.On (b)(6) 2022, an unscheduled intervention occurred for biliary drainage dislodge.The patient required an additional pcts procedure conducted by an interventional radiologist as an inpatient placing a drain.On january 13, 2022, the patient developed fever and dyspnea due to the appearance of a hepatic collection.Drainage of the collection was performed, and antibiotics plus two blood transfusions were given.It was reported that a hepatic embolization was performed on the patient the day after the study procedure.On january 18, 2022, it was indicated that patient discharge was pending.Additional information was received on april 07, 2022: the adverse event of fever and dyspnea are confirmed to be symptoms of sepsis and cholangitis.

Manufacturer Narrative

Additional information: block b5 (describe event or problem).Patient codes fever and dyspnea have been updated to sepsis and cholangitis (inflammation).Correction: block b2 (outcomes attrib to adv event) block d2b (pro code): ntn block e1 initial reporter address: gastroenterology & digestive endoscopy agostino gemelli irccs block h6 (patient codes): the patient code e0306 and e2326 captures the reportable event of patient sepsis and cholangitis.Block h6 (evaluation conclusion codes): conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: SPYGLASS DISCOVER DIGITAL CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13500003
• MDR Text Key: 287110269
• Report Number: 3005099803-2022-00636
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K200483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2023
• Device Model Number: M00546780
• Device Catalogue Number: 4678
• Device Lot Number: 0027290808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female