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

Model Number 30935

Device Problem Material Separation (1562)

Patient Problem Pain (1994)

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported that suture detachment occurred and there was difficulty removing the drainage catheter which resulted in pain without intervention.A flexima all purpose drainage catheter was selected for use in the chest.During removal, the tube was pulled, however, the string retained with two ends coming out of wound.The string was pulled using a lot of force.The procedure was painful and took longer.The suture was completely removed from the patient by a surgeon.No apparent harm was noted with the patient.There were no further complications.

• Brand Name: FLEXIMA APDL
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18607373
• MDR Text Key: 334186270
• Report Number: 2124215-2024-00412
• Device Sequence Number: 1
• Product Code: FFA
• UDI-Device Identifier: 08714729323112
• UDI-Public: 08714729323112
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0031623815
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1