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

Model Number	M0061752730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Investigation analysis: a percuflex plus stent was returned for analysis.A visual evaluation of the returned device found that it was returned with the protective tube loaded and the stent shaft detached in three sections.More over the stent was observed stretched at the proximal section.The suture string was not returned for analysis.Based on the product analysis, it is possible to determine that the failures encountered (stent detached and stretched) were associated with the act off pulling on the retrieval line without removing the protective tube.The dfu states that "the tube should be removed prior to attempting to pull on the retrieval line.Otherwise the line could become caught on the renal coil as it is being pulled through the tube and in some instances can tear or kink the stent." therefore, 'unintended use error caused or contributed to event' is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus stent was to be used during a ureteroscopic holmium laser lithotripsy procedure, for treatment of renal stones to be performed in the kidney, on (b)(6) 2018.According to the complainant, during preparation, it was noticed that the coil/pigtail was detached at the end of the stent.The procedure was successfully completed with the use of another percuflex plus stent.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results; stent broken.

• 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: 8430216
• Report Number: 3005099803-2019-01295
• Device Sequence Number: 198537
• Product Code: FAD
• UDI-Device Identifier: 08714729041207
• UDI-Public: 08714729041207
• 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
• Report Date (Section B): 03/18/2019

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: 02/25/2021
• Device Model Number: M0061752730
• Device Catalogue Number: 175-273
• Device Lot Number: 0021789819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 78