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); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/28/2016
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 pancreatic 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 pancreatic duct which was visible on the radioscopy.On (b)(6) 2016, the ro marker was retrieved by pushing it from biliary tract towards the small intestines using a dilatation 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 pancreatic 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 pancreatic duct which was visible on the radioscopy.On (b)(6) 2016, the ro marker was retrieved by pushing it from biliary tract towards the small intestines using a dilatation 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 10-11, 2017.According to the complainant, an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016, was not completed due to the detached radiopaque (ro) marker.Reportedly, there was actually "no retrieval" for the detached ro marker.The physician is not concerned about the unretrieved radiopaque marker.
Additional Manufacturer Narrative
A visual examination found that the working length torn all the way of the c-channel until the distal tip.The radiopaque (ro) marker was detached from the guidewire lumen and was not returned.An examination of the working length found witness marks indicating the ro marker had been placed inside the lumen during manufacturing.The complaint was consistent with the reported event of radiopaque (ro) marker detached.Most likely, the defect was due to some operational or anatomical aspect of the procedure.Therefore, the most probable root cause for the complaint is operational context.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no other complaints exist for the specified batch.A labeling review was performed, and the information available suggests that the device may not have been used in accordance with the labeling.
Event or Problem Description
It was reported to boston scientific corporation that a tandem rx cannula tapered tip was used in the pancreatic 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 pancreatic duct which was visible on the radioscopy.On (b)(6) 2016, the ro marker was retrieved by pushing it from biliary tract towards the small intestines using a dilatation 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 10-11, 2017.*** according to the complainant, an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016, was not completed due to the detached radiopaque (ro) marker.Reportedly, there was actually "no retrieval" for the detached ro marker.The physician is not concerned about the unretrieved radiopaque marker.

• 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: 6229015
• Report Number: 3005099803-2017-00002
• Device Sequence Number: 16254309
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: (01)08714729301905(17)20180731(10)19514915
• 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,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: 07/31/2018
• Device Model Number: M00545820
• Device Catalogue Number: 4582
• Device Lot Number: 19514915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided; 06/15/2017
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 02/06/2017; 07/11/2017
• 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