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

Model Number M00523450

Device Problems Break (1069); Positioning Failure (1158); Entrapment of Device (1212); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  malfunction  

Event Description

Note: this report pertains to one of two flexima plus biliary stents used during the same procedure with the same event.It was reported to boston scientific corporation that a flexima plus biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2022.The procedure was for drainage to treat pancreatic head cancer.There was a tumor in the duodenal papilla and the angle was tight; reportedly the physician could not get to the duodenal papilla with the scope.During the procedure, when the physician attempted to deploy the flexima plus biliary stent, the guide catheter could not be pulled and a non bsc guidewire was also seemed trapped.It was noted the guide catheter became broken.The device was removed completely.Then, an attempt was made with a flexima plus biliary stent from a different lot; however, the same problem occurred.The procedure was successfully completed with a third flexima plus 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 as no patient injury.

Manufacturer Narrative

Initial reporter's state: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to one of two flexima plus biliary stents used during the same procedure with the same event.It was reported to boston scientific corporation that a flexima plus biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6), 2022.The procedure was for drainage to treat pancreatic head cancer.There was a tumor in the duodenal papilla and the angle was tight; reportedly the physician could not get to the duodenal papilla with the scope.During the procedure, when the physician attempted to deploy the flexima plus biliary stent, the guide catheter could not be pulled and a non bsc guidewire was also seemed trapped.It was noted the guide catheter became broken.The device was removed completely.Then, an attempt was made with a flexima plus biliary stent from a different lot; however, the same problem occurred.The procedure was successfully completed with a third flexima plus 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 as no patient injury.

Manufacturer Narrative

Block e1: initial reporter's state:(b)(6) block h6: medical device code a0401 captures the reportable event of guide catheter broken.Block h10: the returned flexima plus biliary stent was analyzed, and a visual evaluation noted that the push catheter was severely kinked.The guide catheter was detached and it was fully removed from the delivery system.The guide catheter was kinked and stretched.The push catheter suture hole was torn.No other problem with the device were noted.The reported event was confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.After analysis, it was determined that the push catheter was kinked, the guide catheter was stretched, kinked and detached.The suture hole of the push catheter was torn, based on all those conditions there was evidence of a failure deployment and issues through the procedure.It's most likely that during the procedure user manipulation or some tension caused either by the physician's technique and or even by tortuous anatomy or tight stricture caused the kinks on the push catheter, once the push catheter was kinked the user may have experimented difficulties while pulling out the guide catheter which took the user to apply an extra force that ended stretching and kinking the guide catheter, finally this extra force could have detached the guide catheter and as consequence of the tough movement the suture hole got torn.Based on the analysis performed and all the information gathered from the customer and the issues found the overall conclusion code assigned will be "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: FLEXIMA PLUS BILIARY
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14103697
• MDR Text Key: 289260991
• Report Number: 3005099803-2022-01771
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K965147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00523450
• Device Catalogue Number: 2345
• Device Lot Number: 0027580770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1