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

Model Number	M00569810
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallstent biliary rx uncovered stent was implanted to treat a 7-cm malignant stricture in the lower common bile duct (cbd) during biliary stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was dilated prior to stent placement.During the procedure, the stent was deployed successfully under fluoroscopy.However, the physician noted that the distal end of the stent did not fully expand.Additionally, it was noted that the stent wires were kinked and broken at the proximal end of the stent.The stent remains implanted and the physician was comfortable leaving the stent implanted.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.However, the physician will continue to follow up to confirm there are not any issues due to the damaged stent.

• Brand Name: WALLSTENT RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12188654
• Report Number: 3005099803-2021-03602
• Device Sequence Number: 3509765
• Product Code: FGE
• UDI-Device Identifier: 08714729456728
• UDI-Public: 08714729456728
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

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: 09/07/2022
• Device Model Number: M00569810
• Device Catalogue Number: 6981
• Device Lot Number: 0026936710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2021
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1