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

Model Number	M00539290
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Date of event: approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed 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 medwatch 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 (ercp) procedure performed in the bile duct.The exact date of the procedure was not reported.According to the complainant, when the nurse unpacked the flexima biliary stent, she inspected the device and noticed that the guide catheter was ruptured.The device was replaced and the procedure was completed with another flexima biliary stent.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code 1069 has been selected to address the reportable event of guide catheter break.Block h10: the returned flexima biliary stent was analyzed, and a visual evaluation noted that the stent was loaded on the delivery system and the guide catheter was not retracted.The delivery system was free of obvious kinks and bends.No visual issues were observed on the device.A functional evaluation noted that the guide catheter was retracted and the stent was deployed without any issues, the guide catheter was completely removed.No other issues with the device were noted.The reported event was not confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process; the device returned did not have any visual issue, additionally during functional inspection the guide catheter was retracted and the stent was deployed without any issues, also the guide catheter was completely removed to measure the overall length and it was found within specifications, indicating it was not broken.Therefore, no problem detected is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use/product label.Additional informaton: block d4: lot number and updated expiration date.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the bile duct.The exact date of the procedure was not reported.According to the complainant, when the nurse unpacked the flexima biliary stent, she inspected the device and noticed that the guide catheter was ruptured.The device was replaced and the procedure was completed with another flexima biliary stent.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code 1069 has been selected to address the reportable event of guide catheter break.Block h10: 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.Additional informaton: block d4: lot number and updated expiration date.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the bile duct.The exact date of the procedure was not reported.According to the complainant, when the nurse unpacked the flexima biliary stent, she inspected the device and noticed that the guide catheter was ruptured.The device was replaced and the procedure was completed with another flexima biliary stent.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 9823882
• Report Number: 3005099803-2020-00909
• Device Sequence Number: 11545711
• Product Code: FGE
• UDI-Device Identifier: 08714729162605
• UDI-Public: 08714729162605
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2020

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: 07/21/2022
• Device Model Number: M00539290
• Device Catalogue Number: 3929
• Device Lot Number: 0024143610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 04/16/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/10/2020; 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1