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

Model Number	M00534260
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned advanix biliary stent was analyzed, and a visual evaluation noted that the suture thread was attached to the push catheter and it wasn't found broken as reported.The stent was observed kinked and torn at one barb.The push catheter was kinked at some locations.Microscope inspection revealed that the suture hole of the push catheter and the suture hole on the stent were found torn.No other problems with the device were noted.The reported event of suture break as not 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 suture thread wasn't broken, the stent was observed kinked and torn at one barb, the push catheter presented several kinks and microscope inspection revealed that the suture hole of the push catheter and the suture hole on the stent were found torn.Since the suture thread was inspected and it was correctly attached to the push catheter without presenting some break as reported, the reported complaint of "suture break" is not confirmed.The kinked push catheter may be related to user manipulation, some technique applied during procedure and/or tortuous anatomy could have lead this observed issue.Once the push catheter was kinked the user could have experienced difficulties when trying to release the stent.Since these difficulties were present and the user tried to release the stent, the torn areas observed on both suture holes could have been caused by this action, the observed damages (kinked and torn at one barb on the stent) could be related to user manipulation and/or the difficulties mentioned could have also contributed to the observed damages.Review and analysis of all available information indicated that the root cause of the problems found is 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.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2021.During the procedure, the physician could not deploy the stent and it was found that the suture string became broken.The procedure was successfully completed with another advanix 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 stable.Investigation results revealed that the stent broken, therefore this event has been deemed an mdr reportable event.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12408577
• Report Number: 3005099803-2021-04446
• Device Sequence Number: 4181827
• Product Code: FGE
• UDI-Device Identifier: 08714729787358
• UDI-Public: 08714729787358
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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: 12/11/2022
• Device Model Number: M00534260
• Device Catalogue Number: 3426
• Device Lot Number: 0026502502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 57