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

Model Number	M00539240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2018.According to the complainant, when delivering the stent into the patient, the guide catheter was pulled out the push catheter to deploy the stent, however, the suture didn't release and the guide catheter broke.The broken guide catheter remained within the push catheter, enabling the entire device to be removed from the patient in one piece.No other issues were noted and the procedure was completed with another device.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 very good.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2018.According to the complainant, when delivering the stent into the patient, the guide catheter was pulled out the push catheter to deploy the stent, however, the suture didn't release and the guide catheter broke.The broken guide catheter remained within the push catheter, enabling the entire device to be removed from the patient in one piece.No other issues were noted and the procedure was completed with another device.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 very good.Additional information received on 24oct2019.The guide catheter was not broken.The broken part corresponds to the push catheter, at the proximal end of the catheter.
Additional Manufacturer Narrative
Problem code 1069 captures for the reportable event of guide catheter broken.The device has not been received for analysis.Upon receipt and 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.
Additional Manufacturer Narrative
Block f10: problem code 1069 captures for the reportable event of guide catheter broken.Block h10: product analysis the returned flexima biliary stent was analyzed.The stent returned loaded.Kinks were found in the guide catheter at the distal section, additionally, the push catheter suture hole was observed torn.The suture was returned detached.It's important to mention that the one proximal portion of the guide catheter was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.It is most likely that the device could have been manipulated, handling and manipulation during its use could contribute to the found kinks in the device.The kinks in the guide catheter could create resistance and/or friction in the device use.The continuous attempts to release the stent in addition to the encountered kinks could result in the push catheter suture hole torn and the guide catheter break.This device condition could have generated that the suture loose, once that the suture is loosed could cause the suture deployment and stent failure to deploy reported issues 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 biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) according to the complainant, when delivering the stent into the patient, the guide catheter was pulled out the push catheter to deploy the stent, however, the suture didn't release and the guide catheter broke.The broken guide catheter remained within the push catheter, enabling the entire device to be removed from the patient in one piece.No other issues were noted and the procedure was completed with another device.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 very good.***additional information received on (b)(6) 2019* the guide catheter was not broken.The broken part corresponds to the push catheter, at the proximal end of the catheter.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9226057
• Report Number: 3005099803-2019-05185
• Device Sequence Number: 1935387
• Product Code: FGE
• UDI-Device Identifier: 08714729162551
• UDI-Public: 08714729162551
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 04/03/2020

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: 01/01/2022
• Device Model Number: M00539240
• Device Catalogue Number: 3924
• Device Lot Number: 0023125281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/24/2019; 03/11/2020
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/12/2019; 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 70