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

Catalog Number	1013319
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	08/17/2018
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.Manipulation of the device resulted in the reported stretched coils.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 versaturn guide wire was used in the left circumflex coronary artery.After the procedure, the versaturn was being removed from the anatomy and resistance was felt with the anatomy.The entire guide wire was successfully removed, but the coils on the guide wire were unraveled.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.
Event or Problem Description
Subsequent to the previously filed report, the user facility medwatch was received which states, during catheterization, when removing wire the tip remained in the coronary artery.Additional information from the physician was obtained; the physician confirmed that nothing was left behind in the patient.There was no additional information provided.
Additional Manufacturer Narrative
Patient codes: 2687 not labeled.Device codes: 1562 not labeled.(b)(4).Conclusion code 4307 removed.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 resulted in the reported stretched coils and ultimately resulted in the reported tip detachment.There is no indication of a product quality issue with respect to manufacture, design or labeling.(b)(4).

• 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: 7869674
• Report Number: 2024168-2018-07113
• Device Sequence Number: 1964288
• Product Code: DQX
• UDI-Device Identifier: 08717648198458
• UDI-Public: 08717648198458
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103101
• 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,Followup
• Report Date (Section B): 10/16/2018

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: 06/30/2020
• Device Catalogue Number: 1013319
• Device Lot Number: 8071861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR