MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE HEAVYWEIGHT HC; GUIDE WIRE

Catalog Number	1000462H
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	07/01/2019
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 subclavian artery that was heavily calcified and moderately tortuous.During advancement of the guide wire, there was resistance with the very tight stenosis in the artery and the guide wire broke at the subclavian artery.The separated segment was retrieved with surgical access to catch the distal part of the guide wire.The patient was reported to be in good condition.There was no reported adverse patient sequela or a clinically significant delay.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 and dimensional inspection was performed on the returned device.The reported core separation was confirmed.The reported difficulty to advance or position through the anatomy could not be replicated in a testing environment as it was based on operational circumstances.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 operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT BALANCE HEAVYWEIGHT HC
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8824689
• Report Number: 2024168-2019-10346
• Device Sequence Number: 19589804
• Product Code: DQX
• UDI-Device Identifier: 08717648015489
• UDI-Public: 08717648015489
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 01/31/2021
• Device Catalogue Number: 1000462H
• Device Lot Number: 9021971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 10/03/2019
• 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