MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	4557
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(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 was used during a biliary stent placement procedure in the common bile duct on (b)(6) 2019.According to the complainant, during the procedure, when the physician attempted to release the stent, it was noticed that the guide catheter was broken.The broken piece of the guide catheter was retrieved using forceps.The procedure was stopped due to this event and has been rescheduled to another date.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during a biliary stent placement procedure in the common bile duct on (b)(6), 2019.According to the complainant, during the procedure, when the physician attempted to release the stent, it was noticed that the guide catheter was broken.The broken piece of the guide catheter was retrieved using forceps.The procedure was stopped due to this event and has been rescheduled to another date.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Problem code 1069 captures for the reportable event of guide catheter broke.The device was received and analysis is completed.A visual evaluation of the returned device found that the stent was bent in several locations.The push catheter was kinked approximately at 2.3cm from distal end.The guide catheter was detached from the delivery system and it was kinked in several locations, proximal end of the guide catheter was tapered indicating it was properly attached to the pull wire.Based on the product analysis, most likely some procedural/anatomical factors were encountered during the procedure which may have limited the overall performance of the device.Patient anatomy and customer maneuvering during the use of the device can lead to kink/bend the catheters and stent.Once the catheters/stent are kinked/bent, this condition can cause resistance at the moment to retract the pull wire/guide catheter, continued attempts to retract the pull wire/guide catheter in order to release the stent or force applied to retract pull wire/guide catheter can result in guide catheter detachment due to friction between the components (catheters/stent) at kinked areas, it is important to proximal end of the guide catheter was tapered indicating it was properly attached to the pull wire.Therefore the most probable root cause for this event is "adverse event related to procedure".A review of the device history record (dhr) was performed, no anomalies were noted found.

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8587224
• Report Number: 3005099803-2019-02397
• Device Sequence Number: 11172475
• Product Code: FGE
• UDI-Device Identifier: 08714729337874
• UDI-Public: 08714729337874
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/19/2019

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: 08/21/2020
• Device Model Number: 4557
• Device Catalogue Number: 4557
• Device Lot Number: 0021039824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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
• Patient Age: 81 YR