MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) 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	08/04/2017
Type of Reportable Event	Malfunction
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 a tandem rx cannula was used during a procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the c-channel got torn to the tip of the device.The ro marker detached and fell inside the patient.The procedure was completed with another tandem rx cannula.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual examination of the returned device found that the returned unit had the working length torn all the way down the c-channel to the distal tip.The ro marker was not present nor was it returned for analysis; however, an examination of the working length found marks indicating that the ro marker had been placed inside the lumen during manufacturing.The investigation concluded that the working length was torn all the way down the c-channel to the distal tip, and the ro marker was not secured inside the guidewire lumen, causing the ro marker to fall off of the device.It appears that the user pulled the guidewire through the guidewire lumen, tearing the extrusion down to the distal tip.Therefore, the most probable root cause of "operational context" was selected for this complaint due to anatomical/ procedural factors.A review of the device history record (dhr) was performed; no anomalies were noted.
Event or Problem Description
It was reported to boston scientific corporation that a tandem rx cannula was used during a procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the c-channel got torn to the tip of the device.The ro marker detached and fell inside the patient.The procedure was completed with another tandem rx cannula.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 - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6829501
• Report Number: 3005099803-2017-02625
• Device Sequence Number: 44674
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: 08714729301905
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2017

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 Model Number: M00545820
• Device Catalogue Number: 4582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1