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

Model Number	M00534350
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
Note: this report is one of three complaints that pertain to the same event (mfr report # 3005099803-2021-02498, mfr.Report # 3005099803-2021-02500 and mfr.Report # 3005099803-2021-02501).It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2021.During the procedure, when the physician delivered the advanix 12cm 10fr stent into the bile duct, the physician that the stent was too long and needed a shorter 9cm stent.The undeployed advanix-naviflex was removed with suture attached into scope to be exchanged with another shorter 8.5fr 9cm advanix preloaded stent.The physician attempted to insert the 9cm stent but still struggled to come out of the scope into the duodenum and so then exchanged for another 9cm 8.5 fr advanix preloaded stent which also struggled to exit the scope.Both 9cm 8.5 fr advanix preloaded stent was also removed and then it was discovered that the original 10fr 12cm stent was detached from the delivery system in the scope and the suture string was broken during removal and was not noticed.The advanix 12cm 10fr stent was affecting the passage of the following stents.All three advanix stents was successfully removed and no new stent was implanted.The procedure was not completed on this day due to patient became restless and needed percutaneous transhepatic cholangiography.Patient will undergo a rendezvous procedure since endoscopy access was difficult.It was reported that the procedure was rescheduled and completed after two days.There were no known patient complications reported as a result of this 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: 12005692
• Report Number: 3005099803-2021-02498
• Device Sequence Number: 3096577
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/15/2021

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 Model Number: M00534350
• Device Catalogue Number: 3435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1