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

Model Number	M00534320
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021 based on the date the manufacturer became aware of the event.(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-naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography and biliary stenting procedure in the papilla dudeni major and common bile duct, performed on an unknown date.During the procedure and inside the patient, there was difficulty in advancing the guidewire and when the physician attempted to deploy the stent, it was noticed that the gude catheter was ripped off and remained in the common bile duct.All broken pieces of guide catheter was retrieved with a use of snare and another advanix-naviflex stent was opened and was used to successfully complete the procedure.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be fully recovered.A photo of the complaint device was provided and showed that the guide catheter was broken.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2021 based on the date the manufacturer became aware of the event.Block h6: medical device problem code a0401 captures the reportable event of guide catheter break.Block h10: the returned naviflex delivery system was analyzed, and a visual evaluation noted that guide catheter was detached.Microscope inspection revealed that the push catheter suture hole was found torn and the detached end of the guide catheter was inspected under magnification.Media inspection confirmed by the provided photo the break of the guide catheter.The pull wire did not present visual issues and it was retracted at the no return point.The advanix biliary stent was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.Since it was evident that the user was available to pull out totally the pull wire and the pull wire did not present related issues, the reported complaint of pull wire retraction problem is not confirmed.According to product analysis, it is most likely that during the procedure the user may have experienced difficulties to release the stent, difficulties caused by the technique applied, the manipulation on the device and/or even tortuous anatomy could have contributed on these difficulties, these difficulties leaded the torn on the push catheter suture hole and could have contributed on the extra tension submitted to the device which ended detaching part of the guide catheter.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography and biliary stenting procedure in the papilla dudeni major and common bile duct, performed on an unknown date.During the procedure and inside the patient, there was difficulty in advancing the guidewire and when the physician attempted to deploy the stent, it was noticed that the gude catheter was ripped off and remained in the common bile duct.All broken pieces of guide catheter was retrieved with a use of snare and another advanix-naviflex stent was opened and was used to successfully complete the procedure.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be fully recovered.A photo of the complaint device was provided and showed that the guide catheter was broken.

• 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: 12661139
• Report Number: 3005099803-2021-05340
• Device Sequence Number: 1232143
• Product Code: FGE
• UDI-Device Identifier: 08714729787419
• UDI-Public: 08714729787419
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2021
• Device Model Number: M00534320
• Device Catalogue Number: 3432
• Device Lot Number: 0023782184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown