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

Model Number	M00545650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial reporter address: (b)(6).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 in a procedure, performed on (b)(6) 2020.According to the complainant, during preparation, when they tried to load the stent onto the delivery system, the guide catheter became separated.The procedure was "successfuly" completed with another flexima rx biliary stent.There were no patient complications 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
Block h6: device code 1069 captures the reportable event of guide catheter broken.Block e1: initial reporter address: (b)(6).Block h10: product analysis: the returned flexima rx biliary stent was analyzed.A visual evaluation noted that the push catheter was found bent/kinks at the distal section, additionally, the guide catheter was returned detached and the stent loaded on it.The guide catheter detached section was torn at the proximal section.No other issues with the device were noted.The reported event was confirmed.It is possible that operational factors, such as user technique/handling during preparation could contribute to the observed kinks in the push catheter.This device condition could cause resistance during to retract the pull wire/guide catheter, continued attempts to retract the pull wire/guide catheter to release the stent or force applied to retract pull wire/guide catheter can result in a guide catheter torn generating the found guide catheter detachment.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used in a procedure, performed on (b)(6) 2020.According to the complainant, during preparation, when they tried to load the stent onto the delivery system, the guide catheter became separated.The procedure was successfully completed with another flexima rx biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 9687411
• Report Number: 3005099803-2020-00322
• Device Sequence Number: 14366095
• Product Code: FGE
• UDI-Device Identifier: 08714729252221
• UDI-Public: 08714729252221
• 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): 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2022
• Device Model Number: M00545650
• Device Catalogue Number: 4565
• Device Lot Number: 0023745082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1