MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) RX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00545570
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.(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 flexima rx biliary stent was used during biliary drainage procedure performed in the bile duct on (b)(6) 2017.According to the complainant, while releasing the stent, severe resistance was felt on the hand base.When the physician tried to continue the deployment, the guide catheter broke and stayed inside the patient.The stent was pulled out from endoscope and the broken piece of catheter had to be removed by forceps.The procedure was completed with this device.The flexima rx biliary stent was successfully implanted.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the push catheter is kinked several locations.The pull wire is kinked approximately at 15cm from the molded plastic handle.The guide catheter is broken and it was not returned for analysis.A functional evaluation was performed and found that the pull wire was retracted and there was some resistance due to the kinks found.Based on the product analysis, most likely some anatomical/procedural factors were encountered during the procedure which may have limited the overall performance of the device.A device could have been manipulated, since the failures found are issues that could have been generated by excessive manipulation of the device by the user, also interaction with other devices might have impacted the integrity of the device during the procedure.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.Labeling review was performed and no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during biliary drainage procedure performed in the bile duct on (b)(6) 2017.According to the complainant, while releasing the stent, severe resistance was felt on the hand base.When the physician tried to continue the deployment, the guide catheter broke and stayed inside the patient.The stent was pulled out from endoscope and the broken piece of catheter had to be removed by forceps.The procedure was completed with this device.The flexima rx biliary stent was successfully implanted.There were no patient complications reported as a result of this event.

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6939670
• Report Number: 3005099803-2017-02983
• Device Sequence Number: 661531
• Product Code: FGE
• UDI-Device Identifier: 08714729337874
• UDI-Public: 08714729337874
• Combination Product (Y/N): N
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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 Model Number: M00545570
• Device Catalogue Number: 4557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 11/22/2017
• 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