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

Model Number	M0061751970
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was to be used for a urology stent placement procedure in the ureter, performed on (b)(6) 2022.During preparation.After pulling the suture, the stent shaft broke into two pieces.Another percuflex plus ureteral stent was opened and successfully completed the procedure.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional 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 or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was to be used for a urology stent placement procedure in the ureter, performed on (b)(6) 2022.During preparation.After pulling the suture, the stent shaft broke into two pieces.Another percuflex plus ureteral stent was opened and successfully completed the procedure.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of stent shaft break.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the stent shaft was detached in two different sections and the suture hole looks in good condition.The suture was not returned.A functional evaluation noted that a mandrel of 0.036" passed through the stent without resistance.A photo of the device was attached in the complaint record showed that the stent was out of its original pouch and the stent shaft was detached.No other issues with the problems 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 the stent with the shaft detached.Additionally, the suture was not returned indicating that it was removed, and stent was used.Therefore, it is possible to conclude that operational factors, interaction of the device with the suture string before their use such as an entanglement with excess of force applied, could have caused the found issue that were observed.Therefore, failure to follow instructions is selected as the most probable root cause for the complaint.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: 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: 15021599
• Report Number: 3005099803-2022-03683
• Device Sequence Number: 6856789
• Product Code: FAD
• UDI-Device Identifier: 08714729067603
• UDI-Public: 08714729067603
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2024
• Device Model Number: M0061751970
• Device Catalogue Number: 175-197
• Device Lot Number: 0026598677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Sex: Male