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

Model Number	M00534280
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct, performed on (b)(6) 2021.During the procedure, the physician found that the stent could not be deployed.When attempted to retract the guide catheter, it cracked.It was reported that the physician forcibly pulled off the broken guide catheter and it remained within the push catheter enabling the device to be removed in one piece.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.
Additional Manufacturer Narrative
Block e1: initial reporter state: (b)(6).Block h6: medical device code a0401 captures the reportable event of guide catheter broken.Block h10: the returned device only included the naviflex rx delivery system; the stent portion of the advanix biliary stent device was not returned.A visual evaluation noted that the pull wire was extended when received.The push catheter was kinked; also, the push catheter was torn and the pull wire had one part out of it.The pull wire presented kinks.The suture was present on the suture hole in the push catheter.Functional inspection could not be performed due the kinks presented on the pull wire and the tear on the push catheter.Additionally, it was found that the suture hole of the push catheter was torn.No other problems with the device were noted.Upon analysis, it was determined that the push catheter was torn leaving one part of the pull wire out of it, both were kinked and the suture hole on the push catheter was found torn.These issues observed could contribute to an unsuccessful deployment.Therefore, the reported complaint of 'stent failure to deploy' was confirmed.However, the guide catheter was not found to be broken as reported.Additionally, kinks presented on the pull wire and torn push catheter may be related to an extra force applied when trying to retract/extend the pull wire causing the push catheter to be torn and kinking both, also contributing to the unsuccessful deployment.The tear presented on the suture hole on the push catheter may be related to user manipulation and/or some technique applied during the procedure.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 bile duct, performed on (b)(6) 2021.During the procedure, the physician found that the stent could not be deployed.When attempted to retract the guide catheter, it cracked.It was reported that the physicican forcibly pulled off the broken guide catheter and it remained within the push catheter enabling the device to be removed in one piece.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.

• 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: 11817001
• Report Number: 3005099803-2021-02034
• Device Sequence Number: 11693537
• Product Code: FGE
• UDI-Device Identifier: 08714729787372
• UDI-Public: 08714729787372
• 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,Followup
• Report Date (Section B): 06/23/2021

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: 10/16/2021
• Device Model Number: M00534280
• Device Catalogue Number: 3428
• Device Lot Number: 0024612406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 75