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

Catalog Number	1005359H
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	01/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the heavily calcified anatomy 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 the procedure was to treat a 90% stenosed lesion with heavy calcification in a peroneal artery.The whisper guide wire was advanced without resistance and atherectomy was performed.During the procedure the distal tip separated in the vessel.A snare device was not used due to the vessel being narrow and the snare not having enough room to open.A catheter was advanced in attempt to aspirate the separated portion but was unsuccessful.The separated portion remains embedded in the vessel.The patient was stable with no pain or discomfort.The patient is scheduled to return for ultrasound doppler to be reassessed.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: 7387298
• Report Number: 2024168-2018-02367
• Device Sequence Number: 35691
• Product Code: DQX
• UDI-Device Identifier: 08717648037825
• UDI-Public: 08717648037825
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/30/2018

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 Expiration Date: 02/28/2018
• Device Catalogue Number: 1005359H
• Device Lot Number: 6030971
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 03/30/2018
• 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: 69 YR
• Patient Weight: 104