MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYBITE MAX; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00546470
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Sepsis (2067)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a spybite max biopsy forceps was used in the biliary tract during a percutaneous transhepatic cholangiography (ptc) procedure performed on (b)(6) 2021.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.On (b)(6) 2022, hemobilia was noted.The patient was treated with an antibiotic and saline solution.The treatment was resolved and stopped on (b)(6) 2022.On (b)(6) 2022, the patient developed fever and dyspnea, due to the appearance of a hepatic collection.Patient hospitalized on (b)(6) 2022 where drainage of the collection was performed, with antibiotics and two blood transfusions given.Reportedly, the patient undergone hepatic embolization on (b)(6) 2021, the day after ptcs procedure was performed.
Additional Manufacturer Narrative
(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 or Problem Description
It was reported to boston scientific corporation that a spybite max biopsy forceps was used in the biliary tract during a percutaneous transhepatic cholangiography (ptc) procedure performed on (b)(6), 2021.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.On (b)(6), 2022, hemobilia was noted.The patient was treated with an antibiotic and saline solution.The treatment was resolved and stopped on (b)(6), 2022.On (b)(6), 2022, the patient developed fever and dyspnea, due to the appearance of a hepatic collection.Patient hospitalized on (b)(6), 2022 where drainage of the collection was performed, with antibiotics and two blood transfusions given.Reportedly, the patient undergone hepatic embolization on (b)(6), 2021, the day after ptcs procedure was performed.***additional information received as of april 07, 2022*** the adverse event of fever and dyspnea are confirmed to be symptoms of sepsis and cholangitis.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem).Patient codes fever and dyspnea have been updated to sepsis and cholangitis (inflammation).Block h6: patient code e0506 captures the reportable event of hemobilia was noted and was treated with antibiotics and saline solution.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem).Patient codes fever and dyspnea have been updated to sepsis and cholangitis (inflammation).Block h6: patient code e0506 captures the reportable event of hemobilia was noted and was treated with antibiotics and saline solution.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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.Block h11: h6 impact code unexpected medical intervention changed to blood transfusion, and hospitalization or prolonged hospitalization.
Event or Problem Description
It was reported to boston scientific corporation that a spybite max biopsy forceps was used in the biliary tract during a percutaneous transhepatic cholangiography (ptc) procedure performed on (b)(6) 2021.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.On (b)(6) 2022, hemobilia was noted.The patient was treated with an antibiotic and saline solution.The treatment was resolved and stopped on (b)(6) 2022.On (b)(6) 2022, the patient developed fever and dyspnea, due to the appearance of a hepatic collection.Patient hospitalized on (b)(6) 2022 where drainage of the collection was performed, with antibiotics and two blood transfusions given.Reportedly, the patient undergone hepatic embolization on (b)(6) 2021, the day after ptcs procedure was performed.***additional information received as of april 07, 2022*** the adverse event of fever and dyspnea are confirmed to be symptoms of sepsis and cholangitis.***additional information received as of may 4, 2022*** the patient was given antibiotics for fever/sepsis.A blood transfusion was given to treat sepsis/infection.The saline was for flushing the drains.Bleeding was worrisome, but didn't require transfusion for that specifically.The bleeding was observed beyond what's expected for ercp and ptc (described as moderate).There was nothing done to directly treat the hemobilia, just hospitalization.

• Brand Name: SPYBITE MAX
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; boston scientific corporation; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13496817
• Report Number: 3005099803-2022-00424
• Device Sequence Number: 14516135
• Product Code: FCL
• UDI-Device Identifier: 08714729996699
• UDI-Public: 08714729996699
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2024
• Device Model Number: M00546470
• Device Catalogue Number: 4647
• Device Lot Number: 0027690964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 04/07/2022; 05/03/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 05/04/2022; 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female