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

Catalog Number	1005359HJ
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device not returned for analysis.A review of the lot history record and complaint history of the reported levice could not be conducted because the lot number was not provided.As there was no damage noted to the guide wire during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the perclose proglide and/or other devices resulted in the reported tip detachment.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that an arteriotomy closure was being performed on the right femoral artery with a perclose proglide; however, the tip of a whisper guide wire broke off in the patient.The guide wire tip was successfully removed with a snare device.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Common Device Name: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7441975
• Report Number: 2024168-2018-02899
• Device Sequence Number: 19320284
• Product Code: DQX
• UDI-Device Identifier: 08717648037832
• UDI-Public: 08717648037832
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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 Catalogue Number: 1005359HJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/18/2018
• 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: Required Intervention
• Patient Age: 74 YR