MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER RX ERCP CANNULA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	M00545770
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an rx ercp cannula was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the end of the catheter fell off during wire exchange.It is unknown if the ro marker detached; however, the tip of the cannula fell off and was removed from the patient.It is unknown how the procedure was completed.There were no patient complications reported as a result of this event.No injury to the patient was reported at the conclusion of the procedure.
Additional Manufacturer Narrative
A visual examination found that the unit returned was found separated (split/torn) at the bonded areas; moreover, the ro marker was found present at the distal tip section.Only the distal end of the device was returned for evaluation.Based on the investigation results, the device damage could be due to excessive manipulation of the device by the user.The failure is consistent with one which is caused by excessive force which may result in damage, deformities or device breakage.The most probable root cause is operational context.A dhr (device history record) review was performed and no deviation was found.Same lot: no other complaints have been reported for lot number 19961454.Labeling review was performed and no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that an rx ercp cannula was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the end of the catheter fell off during wire exchange.It is unknown if the ro marker detached; however, the tip of the cannula fell off and was removed from the patient.It is unknown how the procedure was completed.There were no patient complications reported as a result of this event.No injury to the patient was reported at the conclusion of the procedure.

• Brand Name: RX ERCP CANNULA
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6662555
• Report Number: 3005099803-2017-01754
• Device Sequence Number: 18884787
• Product Code: GCJ
• UDI-Device Identifier: 08714729268659
• UDI-Public: (01)08714729268659(17)20181114(10)19961454
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K970054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

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: 11/14/2018
• Device Model Number: M00545770
• Device Catalogue Number: 4577
• Device Lot Number: 19961454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 07/25/2017
• 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