MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE GUIDE WIRE

Catalog Number	1001782
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
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.Visual and dimensional analysis was performed on the returned device.The reported difficult to advance was unable to be replicated in a testing environment also due to the condition of the returned components; therefore, it was not confirmed; the report of material separation was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the event.A review of the complaint history identified no other incidents reported for this lot.The investigation determined that the reported difficulties were likely due to case related circumstances.Resistance between the two devices was felt while advancing the guide wire into a micro-catheter through a heavily calcified with total occlusion lesion resulting in the difficulty to advance, and it is likely excessive force was applied resulting guide wire/material separation.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 heavily calcified and chronic total occlusion lesion in the right superficial femoral artery.A 014 bmw guide wire was being advanced into a micro-catheter; however, resistance between the devices was felt and the guide wire separated.The separated guide wire remained in the micro-catheter and were removed as a unit.A new unspecified guide wire and a new micro catheter were used to successfully complete the procedure.There were no adverse patient effects and 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: 9111956
• Report Number: 2024168-2019-12060
• Device Sequence Number: 1748829
• Product Code: DQX
• UDI-Device Identifier: 08717648013843
• UDI-Public: 08717648013843
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/24/2019

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: 03/31/2021
• Device Catalogue Number: 1001782
• Device Lot Number: 9042371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICRO CATHETER: RUBICON 03T