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

Model Number	M006175262010
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus ureteral stent was implanted in the ureter on (b)(6) 2017, and was attempted to be removed during a removal catheter j procedure performed on (b)(6) 2017.According to the complainant, during the removal catheter j procedure, an attempt to remove the percuflex¿ plus ureteral stent was performed; however, distal double j failed to uncoil leaving the stent stuck in the distal end of the ureter.The stent was cut using a holmium laser and the patient was placed under general anesthesia to undergo a two hour surgery.Additionally, it was reported that trauma was noted on the ureter increasing the surgical risk and the possible complications.During the surgery the patient had trauma in the ureter due to handling, but the patient is stable now, without injury, at the conclusion of the procedure.

• Brand Name: PERCUFLEX¿ PLUS
• 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: 6801279
• Report Number: 3005099803-2017-02290
• Device Sequence Number: 16314894
• Product Code: FGE
• UDI-Device Identifier: 08714729340003
• UDI-Public: (01)08714729340003(17)20190731(10)19998781
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: M006175262010
• Device Catalogue Number: 175-262-01
• Device Lot Number: 19998781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention