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

Model Number	26280
Medical Device Problem Codes	Failure to Capture (1081); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported re-sheathing difficulties occurred.The target lesion lesion was located in the iliac artery.A 18x90/10fr uni plus 75cm wallstent endoprosthesis stent was used for treatment.When the physician deployed the stent they tried to retrieve to change the position.However, re-sheathing difficulties occurred.The procedure was completed with another of the same device.No patient complications were reported and the patient status was fine.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).Device evaluated by mfr.: based on the potential root causes identified a visual and tactile examination identified no issues or damage with the delivery system which could potentially have contributed to the complaint incident.Visual and microscopic examination identified no damage to the stent cups or stent holder that could have contributed to the complaint incident.The device was received with the stent fully mounted onto the delivery system.The investigator deployed the stent with no resistance experienced.The stent cups and holder were undamaged.A visual inspection identified damage to the distal stent wires.This type of damage is consistent with the stent encountering resistance during deployment.No issues were identified during the product analysis.
Event or Problem Description
It was reported re-sheathing difficulties occurred.The target lesion lesion was located in the iliac artery.A 18x90/10fr uni plus 75cm wallstent endoprosthesis stent was used for treatment.When the physician deployed the stent they tried to retrieve to change the position.However, re-sheathing difficulties occurred.The procedure was completed with another of the same device.No patient complications were reported and the patient status was fine.

• 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: 8125738
• Report Number: 2134265-2018-63457
• Device Sequence Number: 1732226
• Product Code: JCT
• UDI-Device Identifier: 08714729204084
• UDI-Public: 08714729204084
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/11/2019

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: 09/05/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022614045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/20/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR