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

Model Number	M00510890
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of the procedure was not completed due to this event.
Event or Problem Description
It was reported to boston scientific corporation that a spybite biopsy forcep was used in the common bile duct on an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the forceps could not be removed forceps from the endoscope and were twisted, making it unusable.The procedure was not completed due to this event.There were no known patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a spybite biopsy forcep was used in the common bile duct on an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the forceps could not be removed from the endoscope and were twisted, making it unusable.The procedure was not completed due to this event.There were no known patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of the procedure was not completed due to this event.Block h11: the returned spybite biopsy forceps was analyzed, and visual inspection found the jacket was kinked at two sections.Under magnification, a fracture was noted in the distal section of the jacket.The outer diameter of the device was reviewed with a ring gage and the ring gage was able to pass the distal section of the device.The outer diameter dimensions of the jacket were reviewed and found within specification.With all the available information, boston scientific concludes that the reported event of device difficult to remove was not confirmed.The outer diameter dimensions of the jacket were reviewed and found within specification and the ring gage was able to pass the distal section of the device.In addition, it was found that the jacket of the returned device was kinked and fractured.This could have been generated due to excessive force or manipulation when inserting the spybite biopsy forceps through another device or due to interaction with the scope.The most probable most probable conclusion for the investigation findings of jacket kinked and fractured is adverse event related to procedure.However, the most probable conclusion for the reported event of device difficult to remove is no problem detected.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 instructions for use (ifu) / product label.

• Brand Name: SPYBITE MAX
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; 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: 18427543
• Report Number: 3005099803-2023-06964
• Device Sequence Number: 7856846
• Product Code: FCL
• UDI-Device Identifier: 08714729996699
• UDI-Public: 08714729996699
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2026
• Device Model Number: M00510890
• Device Catalogue Number: 4647
• Device Lot Number: 0031873263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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
• Patient Sex: Unknown