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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual examination found that the tip of the device was damaged (ripped) and the working length was torn all the way from the c-channel to the distal tip.The ro marker was not present and not returned.An examination of the working length found evidence indicating the ro marker had been properly placed inside the lumen during manufacturing.The condition of the returned incident device was consistent with the reported event tip damaged.The investigation further revealed that the working length was split all the way from the c-channel to the distal tip which caused the ro marker to no longer be secure inside the guide wire lumen.An examination of the working length found witness marks indicating the ro marker had been placed inside the lumen during manufacturing.It is most likely that during the preparation the device, the tip could have been smashed due to the interaction with the scope, the interaction with other devices or due to excessive manipulation of the device by the user.It appears the user pulled the guidewire through the guidewire lumen tearing the extrusion to the distal tip.Therefore, due to anatomical/procedural factors encountered during the procedure, the most probable root cause of this complaint is operational context.A review of the device history record (dhr) was performed; no deviations were found.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a tandem rx cannula was used during a bile duct self-expandable metallic stent (sems) procedure performed on (b)(6) 2017.According to the complainant, the cannula tip was found to be broken during the procedure.Reportedly, ii was suspected that the cause was the excessive tension applied when pulling out the cannula.The procedure was completed with another tandem rx cannula.There were no patient complications reported as a result of this event.No patient injury was reported at the conclusion of the procedure.This event has been deemed a reportable event based on the investigation results; ro marker detached.

• 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: 6592846
• Report Number: 3005099803-2017-01670
• Device Sequence Number: 1148601
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: (01)08714729301905(17)20190228(10)20258354
• Combination Product (Y/N): N
• PMA/510(K) Number: K970054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

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 Expiration Date: 02/28/2019
• Device Model Number: M00545820
• Device Catalogue Number: 4582
• Device Lot Number: 20258354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1