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

Model Number	M00547110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.Initial reporter phone: (b)(6).(b)(4).Investigation results: a visual examination of the complaint device revealed that the catheter shaft was broken into two pieces.This failure is likely due to anatomical/procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct (cbd) on (b)(6) 2017.According to the complainant, during the procedure, the catheter shaft was torn in the middle when the stones were removed from the bile duct.The procedure was completed with a different device.There were no patient complications reported as a result of this event.Investigation results showed that the catheter shaft was broken into two pieces; therefore, this is now an mdr reportable event.

• Brand Name: EXTRACTOR¿ PRO XL
• 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: 6990409
• Report Number: 3005099803-2017-03170
• Device Sequence Number: 16451066
• Product Code: FGE
• UDI-Device Identifier: 08714729790402
• UDI-Public: 08714729790402
• Combination Product (Y/N): N
• PMA/510(K) Number: K102082
• 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): 10/10/2017

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 Model Number: M00547110
• Device Catalogue Number: 4711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1