MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE WHISPER MS GUIDE WIRE; GUIDE WIRES

Catalog Number 1005357H

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event - estimated.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that during an onsite visit, the physician told the abbott sales representative that he always uses the 014 whisper ms guide wire in his complex cases.He further explained that for the last month or so he has noticed that when the whisper ms guide wire has been in the anatomy for a long period.It seems to stick to other devices that are in the anatomy.The physician wonders if abbott has changed the coating on the whisper ms guide wire.No specific case or patient event was noted by the physician.No further information was provided.

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Type of Device: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6926651
• MDR Text Key: 90032865
• Report Number: 2024168-2017-08024
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648037801
• UDI-Public: 08717648037801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1005357H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1