MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE GUIDE WIRE

Catalog Number	28000
Medical Device Problem Codes	Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	08/21/2019
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 incident information was reviewed; however, the product was not returned to abbott vascular for analysis.The lot history record or similar incident query was not reviewed since the lot number were not reported.The investigation determined the reported failure to advance and core separation appear to be related to operational circumstances of the procedure.It is likely that during advancement the guide wire became kinked against the anatomy and/or other devices used during the procedure.Manipulation of the guide wire likely resulted in the reported separation and stretched coils.Additionally, the treatment appears to be related to the operational context of the procedure as unspecified stent was used to embed the separated tip.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the distal left anterior descending artery.A 014 hi-torque balance guide wire was advanced to the lesion without resistance; however, the tip unraveled and separated.An unspecified stent was used to embed the separated tip.The rest of the guide wire was removed without issues.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HT BALANCE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8984838
• Report Number: 2024168-2019-11667
• Device Sequence Number: 3275136
• Product Code: DQX
• UDI-Device Identifier: 08717648013423
• UDI-Public: 08717648013423
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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 Catalogue Number: 28000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/10/2019
• 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
• Patient Age: 61 YR
• Patient Weight: 109