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

Model Number 32375

Device Problems Break (1069); Defective Device (2588)

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

Event Date 09/08/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city - (b)(6).

Event Description

It was reported that the catheter broke.A flexima nephrostomy drainage catheter had been placed for drainage of the kidney.It was noted there was difficulty pulling the suture and the catheter broke.A new flexima catheter was used.There were no patient complications reported.

Event Description

It was reported that the catheter broke.A flexima nephrostomy drainage catheter had been placed for drainage of the kidney.It was noted there was difficulty pulling the suture and the catheter broke.A new flexima catheter was used.There were no patient complications reported.

Manufacturer Narrative

E1: initial reporter city - (b)(6).Device analysis by manufacturer: unit returned with its original pouch.The catheter was returned for analysis; moreover, the flexible cannula was loaded in the catheter, and no damages were observed.The flexible cannula was inserted and retracted from the catheter without issues.

• Brand Name: FLEXIMA
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15538783
• MDR Text Key: 304339452
• Report Number: 2124215-2022-38970
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 08714729323303
• UDI-Public: 08714729323303
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

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
• Device Operator: Health Professional
• Device Model Number: 32375
• Device Catalogue Number: 32375
• Device Lot Number: 0029070485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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