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

Catalog Number	1001309JS
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The bmw guide wire referenced is being filed under a separate medwatch report number.Evaluation summary: the device was returned for analysis.The detachment was able to be confirmed.The reported stretch was unable to be confirmed due to the condition of the returned device.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.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 resulted in the reported stretch and ultimately resulted in the reported coil/core detachments.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that procedure was to treat a moderately tortuous and moderately calcified right coronary artery that was 70% stenosed.An unspecified balance middle weight (bmw) guide wire met resistance with an unspecified balloon catheter during advancement.Therefore, a 014 iron man guide wire was used as a buddy wire; however, the iron man guide wire became entangled with the bmw guide wire during removal.The iron man guide wire coil then unraveled and the tip separated outside the anatomy when it was removed independently.The bmw guide wire was removed after the procedure was completed and it was not damaged.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ACS HI-TORQUE IRON MAN 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: 8283038
• Report Number: 2024168-2019-00606
• Device Sequence Number: 167867
• Product Code: DQX
• UDI-Device Identifier: 08717648015748
• UDI-Public: 08717648015748
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 1001309JS
• Device Lot Number: 8061161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1