MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX URINARY DIVERSION STENT SET; CATHETER, NEPHROSTOMY

Model Number M0061602150

Device Problem Unsealed Device Packaging (1444)

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

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a020513- captures the reportable event of packaging seal compromised.

Event Description

It was reported to boston scientific that an percuflex urinary diversion stent set was received on august 07, 2023.It was found that the stent arrived in the facility damaged.It was observed that the packaging was somehow affected by heat.The sterile barrier was compromised.There was no patient involvement, and this device was not used in a procedure.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT SET
• Type of Device: CATHETER, NEPHROSTOMY
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17660668
• MDR Text Key: 322372560
• Report Number: 3005099803-2023-04555
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729297185
• UDI-Public: 08714729297185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061602150
• Device Catalogue Number: 160-215
• Device Lot Number: 0031497488
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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