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

Lot Number 8020771

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: the udi is unknown because the part number was not provided.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the part number was not provided.As the device was not returned for analysis, a conclusive cause for the reported difficulties cannot be determined, however, the product risk assessment identifies this as a foreseeable event.Based on the information reviewed and provided, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the whisper guide wire was missing the hydrophilic coating.There were no reported adverse patient effects.No additional information was provided regarding this issue.

• Brand Name: HI-TORQUE WHISPER 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: 8152170
• MDR Text Key: 130051144
• Report Number: 2024168-2018-09548
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K101116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 8020771
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2018
• 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