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

Model Number	26280
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was fractured.The target lesion was located in a lower extremity vein.A 12x90/8fr uni plus halo 75cm wallstent endoprosthesis was advanced for treatment.However, the device was fractured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.
Event or Problem Description
It was reported that the device was fractured.The target lesion was located in a lower extremity vein.A 12x90/8fr uni plus halo 75cm wallstent endoprosthesis was advanced for treatment.However, the device was fractured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.It was further reported that the fractured device was removed by simply pulling it out.
Additional Manufacturer Narrative
Device evaluated by mfr.: received wallstent uni 8fr device.A visual and tactile examination found the shaft of the returned device to be damaged/stretched beginning at the main valve and extending approximately 35mm distally.This type of damage is consistent with a restriction being encountered and excessive tensile force being applied when attempting to deploy the stent.The stent was returned in the correct position on the delivery system.The investigator successfully deployed the stent with some resistance experienced due to the damage to the shaft.A visual and microscopic examination identified no issues or damage to the deployed stent.A visual and microscopic examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the device was fractured.The target lesion was located in a lower extremity vein.A 12x90/8fr uni plus halo 75cm wallstent endoprosthesis was advanced for treatment.However, the device was fractured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.It was further reported that the fractured device was removed by simply pulling it out.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10443031
• Report Number: 2134265-2020-11533
• Device Sequence Number: 14134817
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: 08714729203971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2020

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: 11/24/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0024824278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 08/21/2020; 09/24/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/01/2020; 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 56