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

Model Number M0061453520

Device Problems Break (1069); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a percuflex ureteral stent was used during a ureterostenosis procedure in the ureter, performed on (b)(6), 2022.During the procedure and inside the patient, the stent failed to deploy which resulted to stent being fractured and leakage of fluid.Another percuflex ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Block h6: medical device problem code a0401 captures the reportable event of stent shaft break.Block h11: correction to block h6: device code update to block b5 based on the additional information received on december 26, 2022.

Event Description

It was reported to boston scientific corporation that a percuflex ureteral stent was used during a ureterostenosis procedure in the ureter, performed on (b)(6) 2022.During the procedure and inside the patient, the stent failed to deploy which resulted to stent being fractured and leakage of fluid.Another percuflex ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information was received on december 26, 2022 with an attached media of the complaint device showing that the stent was buckled/accordion and war ripped/torn.

Event Description

It was reported to boston scientific corporation that a percuflex ureteral stent was used during a ureterostenosis procedure in the ureter, performed on (b)(6), 2022.During the procedure and inside the patient, the stent failed to deploy which resulted to stent being fractured and leakage of fluid.Another percuflex ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information was received on december 26, 2022 with an attached media of the complaint device showing that the stent was buckled/accordion and war ripped/torn.

Manufacturer Narrative

Block h6: medical device problem code a0401 captures the reportable event of stent shaft break.Block h10: the complaint device was not returned, however, there is one video attached.The video shows one percuflex ureteral stent.At first view is possible observed that the device is trying to be insert however it is noted that the device got buckled/accordion in their bladder coil.Cannot detected more issues since the device is not completely visible.No other problems with the device were noted.The complaint of stent torn material is not confirmed, however the complaint stent buckled material is confirmed.After the analysis was performed, most likely the operational factors, the handle and interaction of the device with a guide wire and/or their positioner could have caused the complaint.Did not found evidence from the manufacturing review to indicate that a device malfunctioned because of a process related defect.Is for that reason, based on the information provided, that the failure is confirmed, and the cause undetermined.Additionally, without proper evaluation of the device, it remains unknown the most probable cause that contributed to the event.For the reported complaint of stent torn material is not confirmed due after the media analysis it did not identify a related issue to this allegation since the device is not completely visible, additionally due the device was not return, there is a lack of evidence to confirm the failure.Therefore, cause not established is selected as the most probable root cause for the complaint.

Manufacturer Narrative

Medical device problem code a0401 captures the reportable event of stent shaft break.The returned percuflex ureteral stent was analyzed, and a visual evaluation noted that the bladder coil was buckled/accordioned and torn, and the site port holes were found stretched.The positioner returned was in good conditions, however, their suture was not returned.There is one video attached in the complaint record and it was observed that the device was attempted to be inserted but the device was buckled/accordion in the blader coil.During functional inspection a mandrel of 0.036" passed through the stent without resistance.Finally, under magnification, the bladder coil buckled/accordioned and the site port holes were torn/stretched.No other problems of the device were noted.The reported event was confirmed.According to the product analysis, it was possible to conclude that some operational factors, handle and/or interaction of the device with a guide wire such as with their positioner during the procedure could have generated the found issues.This affects the performance of the device.Therefore, adverse event related to procedure is selected as the probable root cause for the complaint.

Event Description

It was reported to boston scientific corporation that a percuflex ureteral stent was used during a ureterostenosis procedure in the ureter, performed on (b)(6) 2022.During the procedure and inside the patient, the stent failed to deploy which resulted to stent being fractured and leakage of fluid.Another percuflex ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information was received on (b)(6) 2022 with an attached media of the complaint device showing that the stent was buckled/accordion and war ripped/torn.

• Brand Name: PERCUFLEX
• 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: 16043168
• MDR Text Key: 308537827
• Report Number: 3005099803-2022-07621
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: 08714729040279
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K834468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/07/2023

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: M0061453520
• Device Catalogue Number: 145-352
• Device Lot Number: 0028926690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 11/29/2022; 01/13/2023; 03/14/2023
• Supplement Dates FDA Received: 12/28/2022; 02/08/2023; 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• 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 Sex: Male