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

Model Number	M0061752520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteral lithotomy under rigid ureteroscopic procedure in the upper ureter, performed on (b)(6) 2020.According to the complainant, when the physician unpacked the percuflex plus ureteral stent it was found fractured.Another percuflex plus ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteral lithotomy under rigid ureteroscopic procedure in the upper ureter, performed on (b)(6) 2020.According to the complainant, when the physician unpacked the percuflex plus ureteral stent it was found fractured.Another percuflex plus ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.** additional information received on may 14, 2020 ** the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device code 1069 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 device had the suture hole torn and the bladder pigtail was found detached.The suture string was not returned for analysis.No other issues with the device were noted.The reported event was not confirmed.Based on the product analysis, the stent returned without the suture string, it is evidence that the stent was manipulated.Therefore, the failures found (bladder pigtail detached and suture hole torn) are issues that could have been generated by the user or due to the interacting of the device with the suture string.Therefore, adverse event related to procedure, is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteral lithotomy under rigid ureteroscopic procedure in the upper ureter, performed on (b)(6) 2020.According to the complainant, when the physician unpacked the percuflex plus ureteral stent it was found fractured.Another percuflex plus 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 Manufacturer Narrative
Block h6: device code 1069 captures the reportable event of stent shaft break.Block h10: 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 mdr will be filed.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10058400
• Report Number: 3005099803-2020-01907
• Device Sequence Number: 3357849
• Product Code: FAD
• UDI-Device Identifier: 08714729056805
• UDI-Public: 08714729056805
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2020

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: 07/02/2022
• Device Model Number: M0061752520
• Device Catalogue Number: 175-252
• Device Lot Number: 0024052948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 04/21/2020; 06/04/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 05/19/2020; 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 68