MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) PERCUFLEX¿; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061453620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation analysis: a percuflex stent was received for analysis.A visual analysis of the returned device found that the middle section was damaged and the stent was broken.No other anomalies were encountered.Based on the product event analysis, the failure was noted during preparation and outside of the patient.Moreover, the defect noted could have been caused by the user due to excessive manipulation and interaction of the stent with suture.This type of failure is consistent with one caused when a device is pulled strongly and/or was submitted to an excess of force; excess of force may cause damage, deformities or device break.Therefore, based on all the available information it is more likely that the complaint was caused by the handling of the device and the most probable cause is ¿handling damage¿.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.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ stent was used in the ureter for a ureteral holmium laser lithotripsy procedure performed in the ureter on (b)(6) 2018.According to the complainant, during preparation, the stent coil detached when they were pulling off the rear line of the stent.The procedure was completed with another percuflex¿ stent.There were no patient complications reported as a result of this event.The patient's condition was reported to be stable.This event has been deemed a reportable event based on the investigation results; stent broken.

• Brand Name: PERCUFLEX¿
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7606311
• Report Number: 3005099803-2018-01859
• Device Sequence Number: 13876850
• Product Code: FGE
• UDI-Device Identifier: 08714729040330
• UDI-Public: 08714729040330
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K834468
• 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): 05/28/2018

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: 08/07/2020
• Device Model Number: M0061453620
• Device Catalogue Number: 145-362
• Device Lot Number: 20982155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1