MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	31535
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire was fractured.A flexima drainage catheter was selected for use on bile duct blockage.During the procedure, after the device was delivered, the guidewire was fractured in the patient.The device was simply pulled out and completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The catheter was returned with the several accessories; moreover, the 0018" stainless guidewire was observed kinked and broken at the distal end section.This guidewire was received without the hoop protector.The other devices and accessories were not presented with any issue or damage.Dimensional inspection of the guidewire was performed and the measured dimensions were within specification.Under microscope it was possible to observe that the stainless guidewire was kinked and broken at the distal end section.Media analysis was performed based on a photo attached to the complaint record and the stainless guidewire was observed kinked and broken at the distal end section.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the wire was fractured.A flexima drainage catheter kit was selected for use on bile duct blockage.During the procedure, after the device was delivered, the guidewire was fractured in the patient.The device was simply pulled out and completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

• Brand Name: FLEXIMA APDL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12131499
• Report Number: 2134265-2021-08169
• Device Sequence Number: 19940771
• Product Code: FFA
• UDI-Device Identifier: 08714729323471
• UDI-Public: 08714729323471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 12/08/2023
• Device Model Number: 31535
• Device Catalogue Number: 31535
• Device Lot Number: 0026485470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 72