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

Model Number	26280
Medical Device Problem Codes	Positioning Failure (1158); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was removed not fully constrained.The 80% stenosed target lesion was located in the severely tortuous and severely calcified bronchial artery.A 20x55/10fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.However, during the procedure, the stent failed to deploy.The stent was not fully constrained when removed and the tip was outside the sheath.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was stable.
Event or Problem Description
It was reported that the device was removed not fully reconstrained.The 80% stenosed target lesion was located in the severely tortuous and severely calcified bronchial artery.A 20x55/10fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.However, during the procedure, the stent failed to deploy.The stent was not fully reconstrained when removed and the tip was outside the sheath.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.A wallstent uni plus device was received for analysis, the following attributes were examined: a visual and tactile examination identified a shaft kink 50mm proximal from the distal tip.The investigator was unable to deploy the stent due to the shaft kink.This concludes the product analysis.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16240330
• Report Number: 2124215-2023-01831
• Device Sequence Number: 6605532
• Product Code: JCT
• UDI-Device Identifier: 08714729204107
• UDI-Public: 08714729204107
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: 01/05/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0026580982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2021
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 76 KG