MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE ALLSTAR GUIDE WIRE

Catalog Number	1001741S
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/18/2018
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.Manipulation of the device ultimately 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 the procedure was to treat a moderately calcified proximal circumflex and obtuse marginal coronary artery.At the conclusion of the procedure, when all stenting was completed as a 014 allstar guide wire (gw) was being removed, resistance was felt with the anatomy and the gw separated into two pieces.The distal portion of the guide wire still remains in the anatomy.The patient is fine.There was no resistance noted while advancing.It is unknown if the separated portion of the guide wire will be removed.No additional information was provided.

• Brand Name: ACS HI-TORQUE ALLSTAR 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: 7720721
• Report Number: 2024168-2018-05771
• Device Sequence Number: 19086543
• Product Code: DQX
• UDI-Device Identifier: 08717648013829
• UDI-Public: 08717648013829
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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: 03/31/2020
• Device Catalogue Number: 1001741S
• Device Lot Number: 8042561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 07/25/2018
• 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: Disability
• Patient Age: 87 YR
• Patient Weight: 68