MAUDE Adverse Event Report: AV-TEMECULA-CT HT VERSATURN GUIDE WIRE

Catalog Number	1013319
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2018
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 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.Review of the complaint history identified no other similar incidents from this lot.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The mini trek rx referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a chronic total occlusion [cto] lesion in the mildly calcified left anterior descending coronary artery.A versaturn guide wire was used to switch out a non-abbott cto guide wire after crossing the lesion through a micro-catheter.Pre-dilatation was performed with a small non-abbott balloon catheter.The 2.0x15 mm mini-trek was loaded on to the versaturn guide wire, but a lot of resistance was met during loading.Resistance was met during removal of the mini trek from the versaturn guide wire; therefore, the mini trek and the versaturn guide wire were removed together as a unit.Outside the anatomy, the mini trek was able to be removed from the versaturn.A new guide wire was used with a non-abbott balloon to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

• Brand Name: HT VERSATURN 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: 7560869
• Report Number: 2024168-2018-04052
• Device Sequence Number: 2194148
• Product Code: DQX
• UDI-Device Identifier: 08717648198458
• UDI-Public: 08717648198458
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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: 09/30/2019
• Device Catalogue Number: 1013319
• Device Lot Number: 7101761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1