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 Code	Perforation (2001)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f19 captures the reportable event of surgical intervention.
Event or Problem Description
Note: this report pertains to a spyscope ds ii and spybite max biopsy forceps used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used along with a spybite max biopsy forceps during an endoscopic bile duct biopsy procedure performed for the treatment of suspected intrahepatic bile duct cancer on (b)(6) 2023.During the procedure, the patient was scheduled for a biopsy and a specimen was collected from the distal bile duct.When it was about to reach the target porta hepatis, the image of the spyscope ds ii became distorted and was lost after one hour of usage.A second spyscope ds ii was used, and they noticed a bile duct perforation.They were unable to collect the specimen and made a pathological diagnosis.Any forceful or prolonged operations using the device was not performed after two repeated insertions and removals.A surgical intervention was then performed; the physician believed that the perforation was not cause by the spyscope ds ii, but due to the procedural problems that were performed (endoscopic sphincterotomy, endoscopic papillary balloon dilatation and endoscopic papillary large balloon dilation) to the patient.Reportedly, there was no problem with spybite max.There were no future procedures mentioned, and the procedure was completed using another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and is improving.

• Brand Name: SPYBITE MAX
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• 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: 18092412
• Report Number: 3005099803-2023-06117
• Device Sequence Number: 5884538
• Product Code: FCL
• UDI-Device Identifier: 08714729996699
• UDI-Public: 08714729996699
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/08/2023

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: 07/17/2026
• Device Model Number: M00546470
• Device Catalogue Number: 4647
• Device Lot Number: 0032040279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown