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

Model Number	M006175253050
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2018
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 was removed from the ureter and kidney during a ureteroscopy and double j removal procedure performed on (b)(6) 2018.According to the complainant, during removal, it was noticed that the stent was encrusted.It was reported that there was difficulty in removing the stent, and it took more than two hours to remove.The patient's condition at the conclusion of the procedure was reported to be ¿stable¿.Attempts to gain further information regarding the event have been unsuccessful to date, should any relevant information be provided, a supplemental mdr will be filed.

• 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: 7341786
• Report Number: 3005099803-2018-00789
• Device Sequence Number: 16722396
• Product Code: FGE
• UDI-Device Identifier: 08714729339977
• UDI-Public: 08714729339977
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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): 02/25/2018

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: 01/31/2020
• Device Model Number: M006175253050
• Device Catalogue Number: 175-253-05
• Device Lot Number: 0020626225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2018
• Initial Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1