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

Model Number M0061602100

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2023, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.

Event Description

It was reported to boston scientific corporation that a percuflex urinary diversion stent set was used during a catheter replacement procedure.The exact event date was not reported.During preparation, when the device was unpacked, a kink was discovered.It was also noted that the stent shaft was broken in half.The procedure was completed using another percuflex urinary diversion stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2023, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Block h10: the returned urinary diversion stent was analyzed, and a magnification and visual evaluation noted that the coil kinked, and the shaft detached.A functional test with a guidewire was performed in order to see clearer the kinked reported.No other problems with the device were noted.The reported event of stent kinked, and stent shaft break was confirmed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is probable that the problem of stent kinked was caused due to the interaction between the guidewire and the stent device as well, such as the handling of the device could have contributed with the complaint event reported.Also, for the reported problem of stent shaft break, based on the irregular shape of the detached tips, there is enough evidence to conclude that the device was cut.Therefore, all compiled information on this investigation determines that the most probable cause is unintended use error cause or contributed to event, since the interaction between the user and device, or sample, caused or contributed to the error.

Event Description

It was reported to boston scientific corporation that a percuflex urinary diversion stent set was used during a catheter replacement procedure.The exact event date was not reported.During preparation, when the device was unpacked, a kink was discovered.It was also noted that the stent shaft was broken in half.The procedure was completed using another percuflex urinary diversion stent.There were no patient complications reported as a result of this event.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18031167
• MDR Text Key: 326867517
• Report Number: 3005099803-2023-05705
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729297178
• UDI-Public: 08714729297178
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K830803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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: M0061602100
• Device Catalogue Number: 160-210
• Device Lot Number: 0029622303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• 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
• Patient Race: Asian