MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXTRACTOR PRO XL; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00547100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the device lot number; therefore, the manufacture and expiration date is unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2018.According to the complainant, during the procedure, the extractor device became stuck.The device was continued to be pulled, and the catheter ultimately broke.It was also noted that the coating of the guidewire had sheared off.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported as a result of the event.

• Brand Name: EXTRACTOR PRO XL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8001625
• Report Number: 3005099803-2018-60961
• Device Sequence Number: 203460
• Product Code: FGE
• UDI-Device Identifier: 08714729790389
• UDI-Public: 08714729790389
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K102082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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 Model Number: M00547100
• Device Catalogue Number: 48779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1