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

Model Number	M0061453510
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 report will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex ureteral stent was used during a transurethral nephrolithotomy procedure performed on (b)(6) 2021.According to the complainant, the physician found the stent was broken along the shaft and the pigtail coil was detached.The procedure was completed with another of the same device.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 e1: initial reporter state: (b)(6).Block h6: device code a0401 captures the reportable event of stent shaft break.Block h10: the returned percuflex ureteral stent was analyzed, and a visual evaluation noted that the proximal section (bladder pigtail) was detached 4.7 cm from the tip.A functional evaluation noted that a mandrel was able to be inserted through the device with no resistance.The suture string was returned loaded and cut with the device.No other problems with the device were noted.The reported event was confirmed.Analysis of the returned device revealed that the proximal section (bladder pigtail) was detached 4.7 cm from the tip.This problem found could have been interpreted by the customer as the reported event of stent shaft break and coil detached, however only coil detached was confirmed.The problem found of bladder pigtail detached is an problem that could have been generated by the user or due to interacting of the device with the suture string or other devices involved during preparation and procedure.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex ureteral stent was used during a transurethral nephrolithotomy procedure performed on (b)(6) 2021.According to the complainant, the physician found the stent was broken along the shaft and the pigtail coil was detached.The procedure was completed with another of the same device.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.

• Brand Name: PERCUFLEX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11267320
• Report Number: 3005099803-2021-00315
• Device Sequence Number: 19647468
• Product Code: FAD
• UDI-Device Identifier: 08714729040262
• UDI-Public: 08714729040262
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K834468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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: 11/28/2022
• Device Model Number: M0061453510
• Device Catalogue Number: 145-351
• Device Lot Number: 0024849602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 67