MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER FLEXIMA¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00539280
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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¿ biliary preloaded stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2017.According to the complainant, during the procedure, it was noticed that the guide catheter was detached inside the patient.The physician used forceps to retrieve the device and the procedure was completed with another stent.There were no patient complications as a result of this procedure, and the patient's condition at the conclusion of the procedure is reported to be "stable.".
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the guide catheter is broken in several sections.Two sections of the guide catheter were stuck in the guidewire, both sections are stretched and one section is buckled.The other section that is not stuck in the guidewire is stretched in the proximal section and it is bent throughout.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 condition due to patient anatomy or customer use/manipulation/ can cause the device to bend/coil leading to kinks and bends in catheters.With the catheters bound by kinks and bends, the device would become difficult to deploy stent.Continued effort to deploy the stent or excessive force to deploy the stent likely caused stretching of the guide catheter and eventually breaking the guide catheter.Stretching and breaking of the guide catheter could cause the guide catheter caught in the guide wire.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¿ biliary preloaded stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2017.According to the complainant, during the procedure, it was noticed that the guide catheter was detached inside the patient.The physician used forceps to retrieve the device and the procedure was completed with another stent.There were no patient complications as a result of this procedure, and the patient's condition at the conclusion of the procedure is reported to be "stable.".

• Brand Name: FLEXIMA¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6515871
• Report Number: 3005099803-2017-01268
• Device Sequence Number: 13785753
• Product Code: FGE
• UDI-Device Identifier: 08714729162599
• UDI-Public: (01)08714729162599(17)20180331(10)17815774
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 04/13/2017

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 Expiration Date: 03/31/2018
• Device Model Number: M00539280
• Device Catalogue Number: 3928
• Device Lot Number: 17815774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2017
• 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