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

Model Number	M00534280
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
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 tract performed on (b)(6) 2020.According to the complainant, during the procedure, the stent could not deploy.The guide catheter was torn.The broken piece remain within the push catheter enabling the device to be removed in one piece.The procedure was completed with another of same device.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: zhejiang province.Block h6: device code 1069 captures the reportable event of guide catheter broken.Block h10: the returned advanix naviflex biliary stent was analyzed, and a visual evaluation noted that the pull wire was kinked and dislodged, pull wire cap was found detached, the push catheter and push catheter suture hole were both torn.Additionally, the push catheter was cut and the guide catheter was attached to the pull wire.There were no issues found with the guide catheter.A functional evaluation was not performed due to the condition of the device.No other issue with the device were noted.The reported event of guide catheter broke was not confirmed.Based on the provided and collected information, handling and manipulation of the device during its use can lead the catheters to be kinked/bent, user technique when they insert the unit into the scope contributed to the observed kinks of the catheters.This device condition could have caused friction between the components at kinked/bent areas in the catheters.Continued attempts to release the stent or force retracting the guide catheter in order to release the stent could result in pull wire and push catheter condition.Additionally, the suture hole torn indicates that the suture was properly placed in the device and it was submitted to tension forces resulting in tearing the suture hole and finally detaching the cap from the delivery system.Therefore, the most probable root cause for this event is "adverse event related to procedure".Also, since the guide catheter was attached to the pull wire, therefore the conclusion code for this as reported code will be no problem detected , this indicates the device complaint or problem cannot be confirmed.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 tract performed on (b)(6) 2020.According to the complainant, during the procedure, the stent could not deploy.The guide catheter was torn.The broken piece remain within the push catheter enabling the device to be removed in one piece.The procedure was completed with another of same device.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.See investigation for results.

• 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: 11109261
• Report Number: 3005099803-2020-06528
• Device Sequence Number: 1115251
• 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): 02/15/2021

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: 06/23/2021
• Device Model Number: M00534280
• Device Catalogue Number: 3428
• Device Lot Number: 0024002232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 69