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

Model Number 31535

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Event 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.

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 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
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12131499
• MDR Text Key: 260426132
• Report Number: 2134265-2021-08169
• Device Sequence Number: 1
• Product Code: FFA
• UDI-Device Identifier: 08714729323471
• UDI-Public: 08714729323471
• Combination Product (y/n): N
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 72