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

Model Number	31535
Medical Device Problem Code	Material Split, Cut or Torn (4008)
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 catheter tip split.A flexima apdl drainage catheter was selected for use for a bile duct blockage.During unpacking, it was noted that the tip of the device was split and cracked and could not be used.The device had not entered the patient's body.No patient complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The catheter was returned with the several accessories.Visual examination revealed the accustick was torn at the distal end section.The other devices and accessories did not show any issue or detached section.
Event or Problem Description
It was reported that the catheter tip split.A flexima apdl drainage catheter was selected for use for a bile duct blockage.During unpacking, it was noted that the tip of the device was split and cracked and could not be used.The device had not entered the patient's body.No patient 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: 12159752
• Report Number: 2134265-2021-08305
• Device Sequence Number: 14633543
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 06/25/2022
• Device Model Number: 31535
• Device Catalogue Number: 31535
• Device Lot Number: 0024017746
• 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: 07/13/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 75