MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER 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	04/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 set was used during an endoscopic stent placement procedure performed in the biliary tract on (b)(6) 2017.According to the complainant, during the procedure, after the stent was deployed, it was observed under endoscopic image that the inner guide catheter had detached and was seen coming out from the lumen part of the stent.The physician attempted to remove the broken guide catheter piece from the stent, however, when the object was pulled it was noticed that the stent itself was pulled out as well.Therefore, the entire broken catheter piece and the stent was retrieved and totally removed from the patient.The procedure was completed with another flexima rx biliary stent.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 was kinked approximately at 10 cm and 68.5 cm from the distal end of the guide catheter.The pull wire is bent approximately at 17 cm from the molded handle.The guide catheter was broken from the delivery system, the most proximal section is tapered indicating that it was properly attached to the device during manufacturing, also it is bent/kinked in several locations.Based on the product analysis, most likely some operational/anatomical factors were encountered during the procedure which may have limited the overall performance of the device.A device under tortuous conditions due to patient anatomy or customer use/manipulation/maneuvering can cause the device to bend/coil leading to kinks and bends in the device.Bound by kinks and bends the device would become unable to deploy stent.Continued effort to deploy the stent would cause breaking of guide catheter and bending the pull wire at the proximal section.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified batch.A labeling review was performed and no anomaly was found.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent set was used during an endoscopic stent placement procedure performed in the biliary tract on (b)(6) 2017.According to the complainant, during the procedure, after the stent was deployed, it was observed under endoscopic image that the inner guide catheter had detached and was seen coming out from the lumen part of the stent.The physician attempted to remove the broken guide catheter piece from the stent, however, when the object was pulled it was noticed that the stent itself was pulled out as well.Therefore, the entire broken catheter piece and the stent was retrieved and totally removed from the patient.The procedure was completed with another flexima rx biliary stent.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 - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6556863
• Report Number: 3005099803-2017-01452
• Device Sequence Number: 16416157
• Product Code: FGE
• UDI-Device Identifier: 08714729337874
• UDI-Public: (01)08714729337874(17)20180228(10)17665696
• Combination Product (Y/N): N
• PMA/510(K) Number: K965147
• 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): 04/28/2017

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: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: M00545570
• Device Catalogue Number: 4557
• Device Lot Number: 17665696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 05/31/2017
• 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