MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE FLOPPY II GUIDE WIRE

Catalog Number	22339MS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2018
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 and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the guide wire was between the old stent and the new stent interaction and/or manipulation resulted in the reported detachment as the guide wire was being pulled back.There is no indication of a product quality issue with respect to manufacture, design or labeling.User facility medwatch report (b)(4).
Event or Problem Description
It was reported that the patient was being treated with a new non-abbott drug eluting stent on a previously implanted stent in the right coronary artery.A high-torque (ht) floppy ii guide wire and an unknown guide wire were advanced as buddy wires; however, the unknown guide wire was removed from the anatomy before the new stent was deployed.The ht floppy guide wire was between the old stent and the new stent and when it was pulled back gently the tip separated.The tip of the guide wire was not able to be pulled back and the tip snared; less than 1mm tip was left sandwiched against the vessel wall in between the old stent and new stent.Flow was good and the patient had no chest pain, no ekg changes, and cineangiogram after giving intracoronary nitroglycerin showed excellent mid flow distally.The patient is doing well and was advised to continue aspirin, plavix, and dual antiplatelet therapy.No additional information was provided.

• Brand Name: HI-TORQUE FLOPPY II GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7262020
• Report Number: 2024168-2018-00996
• Device Sequence Number: 1222870
• Product Code: DQX
• UDI-Device Identifier: 08717648080098
• UDI-Public: 08717648080098
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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: 22339MS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/09/2018
• 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: Other
• Patient Age: 59 YR
• Patient Weight: 100