MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Catalog Number	1013319
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the mid left anterior descending coronary artery that was mildly calcified.During use, the versaturn guide wire unraveled and was retrieved with assistance using a balloon catheter.There was no reported adverse patient effect or a clinically significant delay in procedure.A replacement device was used to complete the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the 30-day initial medwatch report, additional information was received which indicated that the guide wire unraveled in the guide catheter at the end of the procedure.However, the procedure was successfully completed after snaring with a non-compliant balloon.The final patient outcome was good.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.A visual inspection was performed and the reported guide wire break and stretched coils were confirmed.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 similar incidents reported from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the reported information, it is likely that manipulation during the procedure and/or retraction the guide wire became kinked causing and the coils to unravel and stretch and resulting in resistance.Additional manipulation and/or inadvertent torqueing of the guide wire likely resulted in the noted separation of the core/coils and bends while in the guiding catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8874915
• Report Number: 2024168-2019-10675
• Device Sequence Number: 16791165
• Product Code: DQX
• UDI-Device Identifier: 08717648198458
• UDI-Public: 08717648198458
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 03/31/2021
• Device Catalogue Number: 1013319
• Device Lot Number: 9040861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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: Required Intervention