MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER RAPID EXCHANGE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	M00545820
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a tandem rx cannula tapered tip was used in the bile duct during a biliary catheterization procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the radiopaque (ro) marker of the cannula was detached and remained inside the patient's bile duct.The physician successfully retrieved the detached piece using an extractor balloon.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional information relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that a tandem rx cannula tapered tip was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the radiopaque (ro) marker of the cannula was detached and remained inside the patient's bile duct.The physician successfully retrieved the detached piece using an extractor balloon.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional information relevant details become available, a supplemental report will be submitted.***additional information as of january 10, 2017.*** the procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion was reported to be stable.

• Brand Name: RAPID EXCHANGE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6231165
• Report Number: 3005099803-2017-00001
• Device Sequence Number: 954619
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: (01)08714729301905(17)20181031(10)19815758
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K970054
• 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,Followup
• Report Date (Section B): 12/12/2016

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: 10/31/2018
• Device Model Number: M00545820
• Device Catalogue Number: 4582
• Device Lot Number: 19815758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 02/03/2017
• 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