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

Model Number	M00545820
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 a tandem rx cannula tapered tip was used in the bile duct during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the radiopaque (ro) marker band detached into the bile duct when the device was pulled.The tip of the device was also torn when the device was removed from the scope.In the physician's assessment, the ro marker will pass naturally.The procedure was completed with a second tandem rx cannula tapered tip.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(device codes): problem code 2907 captures the reportable event of ro marker band detached.Visual examination of the returned device revealed that the working length was free of obvious kinks and bends.The ro marker was not present in the device.The device was inspected under magnification, and it was observed that the guidewire lumen was completely torn, which is evidence that the guidewire was pulled through the catheter wall.Analysis of the returned device indicated that the guidewire was pulled through the catheter wall, causing the guidewire lumen to tear and the ro marker to detach.Based on the information available, it is most likely that the customer pulled the guidewire through the catheter wall instead of following the directions for use in the device removal section.Therefore, the investigation conclusion code for the reported complaint will be documented as failure to follow instructions, since the problems traced to the user not following the manufacturer's instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
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 procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the radiopaque (ro) marker band detached into the bile duct when the device was pulled.The tip of the device was also torn when the device was removed from the scope.In the physician's assessment, the ro marker will pass naturally.The procedure was completed with a second tandem rx cannula tapered tip.There were no patient complications reported as a result of this event.

• Brand Name: RAPID EXCHANGE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8758249
• Report Number: 3005099803-2019-03416
• Device Sequence Number: 11182486
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: 08714729301905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/21/2019

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: 09/03/2020
• Device Model Number: M00545820
• Device Catalogue Number: 4582
• Device Lot Number: 0022602112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1