MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

Model Number	26665
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	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The device was received with the stent fully mounted on the delivery system.Blood was observed on the stent and delivery system of the returned device.The stent wires at the distal end of the stent were noted to be twisted and had penetrated through the outer sheath of the device prior to investigator attempting to deploy the stent.The investigator was unable to deploy the stent due to the stent wires protruding through the outer.A visual and tactile inspection of the device identified that stent wires had penetrated through the outer sheath of the device.A separation of the outer sheath was also noted located approximately 180mm proximal of the tip.No other issues were noted with the delivery system.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 26-jul-2019.It was reported that catheter break below the hub occurred.The target lesion was located in a vessel in the groin.A 8x29mm, 5f, 135cm carotid monorail stent was selected for use.However, during procedure, the plastic outer catheter broke free from the handle.The device was removed and replaced with another of the same device and the procedure was completed.No patient complications were reported and patient status was fine.However, returned device analysis revealed stent damage.

• Brand Name: CAROTID WALLSTENT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8884701
• Report Number: 2134265-2019-09562
• Device Sequence Number: 19308652
• Product Code: NIM
• UDI-Device Identifier: 08714729781202
• UDI-Public: 08714729781202
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2019

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: 10/24/2020
• Device Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0020563705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1