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

Model Number	M00545570
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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 stent replacement in the common bile duct performed on (b)(4) 2019.It was noted that a local anesthesia was used in the procedure but it did not work well and the patient would not calm down.According to the complainant, during the procedure, when the stent was released, a severe resistance was encountered and the guide catheter broke.A snare was used to retrieve the broken guide catheter from the patient.The procedure was completed with this device.The patient's condition at the conclusion of the procedure was reported as 'no problem'.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during a stent replacement in the common bile duct performed on (b)(6) 2019.It was noted that a local anesthesia was used in the procedure but it did not work well and the patient would not calm down.According to the complainant, during the procedure, when the stent was released, a severe resistance was encountered and the guide catheter broke.A snare was used to retrieve the broken guide catheter from the patient.The procedure was completed with this device.The patient's condition at the conclusion of the procedure was reported as 'no problem'.
Additional Manufacturer Narrative
Block f10: problem code 1069 captures for the reportable event of guide catheter broken.Block h10: a visual evaluation of the returned flexima rx biliary stent was performed.The product revealed that the guide catheter was found detached and it was not returned for analysis, additionally, it was observed kinks in the push catheter proximal section; consequently, confirming the reported event of guide catheter broke.However, the stent was not returned for analysis, which indicates that the stent was deployed during procedure; consequently, not confirming the reported complaint of stent failure to deploy.Medial inspection was performed, the customer provided some pictures of the device, the pictures showing that the guide catheter was detached and kinked.Based on the product analysis, it is possible that operational factors, such as user technique/handling during procedure contributed to the observed kinks to along of the device.This device 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.Therefore the most probable root cause for this event is "adverse event related to procedure" since the event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed, no anomalies were 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: 9397953
• Report Number: 3005099803-2019-05774
• Device Sequence Number: 11187313
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 10/21/2021
• Device Model Number: M00545570
• Device Catalogue Number: 4557
• Device Lot Number: 0022824413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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