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

Model Number	M00532190
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The returned advanix biliary stent was analyzed, and a visual evaluation noted that the stent was severely kinked and damaged.No other issues 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 stent was kinked and damaged, the coils of the stent failed to curl.It's most likely that the kinks and damages observed on the stent may be related to user manipulation while preparing the stent and/or anatomical factors could have contributed on this issue during the procedure, also it's possible that the anatomical factors plus the technique performed during procedure caused the issue of the coils failing to curl or maintain the correct shape, in summary those conditions on the stent avoided the correct deployment of it.Therefore, 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 boston scientific corporation that an advanix biliary stent was used during an obstructive jaundice procedure in the lower common bile duct performed on (b)(6) 2021.During the procedure, when the advanix biliary stent was placed in the bile duct, it became kinked after withdrawing the push catheter.It was noted that they had difficulty separating the advanix biliary stent from the push catheter upon reaching the end of the stent.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 was damaged, therefore this event has been deemed an mdr reportable event.Please see for full investigation details.
Additional Manufacturer Narrative
(b)(6).(b)(4).The returned advanix biliary stent was analyzed, and a visual evaluation noted that the stent was severely kinked and damaged.No other issues 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 stent was kinked and damaged, the coils of the stent failed to curl.It's most likely that the kinks and damages observed on the stent may be related to user manipulation while preparing the stent and/or anatomical factors could have contributed on this issue during the procedure, also it's possible that the anatomical factors plus the technique performed during procedure caused the issue of the coils failing to curl or maintain the correct shape, in summary those conditions on the stent avoided the correct deployment of it.Therefore, 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 boston scientific corporation that an advanix biliary stent was used during an obstructive jaundice procedure in the lower common bile duct performed on (b)(6) 2021.During the procedure, when the advanix biliary stent was placed in the bile duct, it became kinked after withdrawing the push catheter.It was noted that they had difficulty separating the advanix biliary stent from the push catheter upon reaching the end of the stent.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 was damaged, therefore this event has been deemed an mdr reportable event.Please see for full investigation details.

• Brand Name: ADVANIX BILIARY
• Common Device Name: 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: 13470844
• Report Number: 3005099803-2022-00301
• Device Sequence Number: 17222119
• Product Code: FGE
• UDI-Device Identifier: 08714729786986
• UDI-Public: 08714729786986
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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: 08/05/2022
• Device Model Number: M00532190
• Device Catalogue Number: 3219
• Device Lot Number: 0025814250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG