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

Model Number 26605

Device Problems Entrapment of Device (1212); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(6).

Event Description

It was reported that entrapment on guidewire occurred.The target lesion was located in the internal carotid artery.A 10.0-31 carotid wallstent was selected for use.During the procedure, there was difficulty advancing the stent over the guidewire.The stent became stuck on the wire and both were removed from the patient.The procedure was completed with another of the same guidewire and stent.There were no patient complications and the patient was fine.

Manufacturer Narrative

A2: age at time of event: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr: the device was returned loaded on to the customer guidewire.The device was covered in a red blood like substance.The outer diameter of the guidewire used by the customer was confirmed to measure 0.0135 inch using a snap gauge.During product analysis the customer guidewire was found to be frozen inside the guidewire lumen of the returned device.A microscopic examination identified a blockage at the guidewire port of the device.The customer guidewire was removed.A microscopic examination identified that the polymer coating of the customer guidewire was damaged, peeling and bunched up at more than one location.It is unknown what could have caused this to happen.A new boston scientific 0.014 inch filterwire was successfully inserted through this device with no resistance or issues experienced.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent fully mounted in the correct place on the device.

Event Description

It was reported that entrapment on guidewire occurred.The target lesion was located in the internal carotid artery.A 10.0-31 carotid wallstent was selected for use.During the procedure, there was difficulty advancing the stent over the guidewire.The stent became stuck on the wire and both were removed from the patient.The procedure was completed with another of the same guidewire and stent.There were no patient complications and the patient was fine.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9990640
• MDR Text Key: 188886986
• Report Number: 2134265-2020-05467
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0024763098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: 0.014 INCH ALLSTAR WIRE; GUIDEWIRE: 0.014 INCH ALLSTAR WIRE