MAUDE Adverse Event Report: ABBOTT VASCULAR HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING

Model Number	1005357H
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Rash (2033)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.Based on the information provided, the investigation determined that the reported separation, entrapment of the device and device damage by another device appear to be due to circumstances of the procedure.Additionally, the device embedded in vessel, skin irritation, delay in procedure and prolonged hospitalization are related to the circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat an obtuse marginal lesion.Post implantation of an unspecified stent, a whisper ms guide wire became trapped under the deployed stent and the proximal portion of the core snapped while attempting to remove it.The patient remained stable while trying to retrieve the wire, additional contrast/radiation was experienced by the patient.Further stenting was performed to secure the separated guide wire portion.The patients hospitalization was prolonged by a day and skin irritation was reported due to the extra radiation exposure.A clinically significant delay was reported.No additional information was provided.

• Brand Name: HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10449887
• Report Number: 2024168-2020-07078
• Device Sequence Number: 3960541
• Product Code: DQX
• UDI-Device Identifier: 08717648037801
• UDI-Public: 08717648037801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 1005357H
• Device Catalogue Number: 1005357H
• Device Lot Number: 0022571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 91