MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number M0061752530

Device Problems Entrapment of Device (1212); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure, performed on (b)(6) 2022.During the procedure, a terumo guidewire was inserted in the stent to place inside the patient, when the physician attempted to remove the guidewire back, the stent got stuck and got crumpled.The procedure was completed and it was unknown what model of stent completed the procedure.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure, performed on july 07, 2022.During the procedure, a terumo guidewire was inserted in the stent to place inside the patient, when the physician attempted to remove the guidewire back, the stent got stuck and got crumpled.The procedure was completed and it was unknown what model of stent completed the procedure.There were no patient complications reported as a result of this event.Additional information received on august 23, 2022: the procedure was performed for a stone in upper ureter.The patient outcome was reported to be good.

Manufacturer Narrative

Block h6: medical device problem code a040601 captures the reportable event of stent buckled/accordion inside the patient.Block h11: additional information received on 23aug2022 to update b5; block d7a: sud reprocessed and reused? block e1: initial reporter address 1: (b)(6).

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure, performed on (b)(6) 2022.During the procedure, a terumo guidewire was inserted in the stent to place inside the patient, when the physician attempted to remove the guidewire back, the stent got stuck and got crumpled.The procedure was completed and it was unknown what model of stent completed the procedure.There were no patient complications reported as a result of this event.Additional information received on august 23, 2022: the procedure was performed for a stone in upper ureter.The patient outcome was reported to be good.

Manufacturer Narrative

Block e1: initial reporter address 1: (b)(6).Block h6: medical device problem code a040601 captures the reportable event of stent buckled/accordion inside the patient.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the bladder pig tail buckled accordion, side port and suture holes stretched out, and bladder coil tip torn.Additionally, the suture and positioner were not returned.For the functional inspection a mandrel of 0.036" was loaded into the device and no resistance was felt.No other problems with the device were noted.The reported event was confirmed.According to the product analysis, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It was found that the device has the bladder coil buckled/accordion.Also, during analysis, it was found that side port holes and suture holes were stretched, and the tip torn.Additionally, the suture was not returned, which means that it was removed, indicating that the stent was used.According to the evidence, it is possible that operational factors, such as interacting of the device with positioner, interaction with another device (guide wire) could cause the buckled/accordion and the holes got stretched and the tip was torn, consequently, affect the performance of the device.These issues could at the same time cause that the device guidewire stuck, however it was not confirmed due the functional inspection have passed and did not find any related issue.For that reason, no problem detected will be coded for the device guidewire stuck since the device complaint could not be confirmed.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.

• Brand Name: PERCUFLEX PLUS
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• 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: 15142613
• MDR Text Key: 304807354
• Report Number: 3005099803-2022-04102
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• UDI-Public: 08714729056812
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K924608
• 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,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061752530
• Device Catalogue Number: 175-253
• Device Lot Number: 0028644818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2022
• 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 Age: 32 YR
• Patient Sex: Female