MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE GUIDE WIRE

Catalog Number	1001782J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.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.
Event or Problem Description
It was reported the procedure was to treat a tortuous lesion in the subclavian artery.The bmw guide wire was advanced with a non-abbott vascular support system was used to help pass the bmw guide wire.While advancing the guide wire separated with part of the guide wire remaining in the subclavian.The separated portion was removed with a snare device.There was no clinically significant delay in the procedure and no adverse patient effects.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.Product performance engineering reviewed the incident information; however, the product 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 similar incidents reported from this lot.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.Based on the reported information, during advancement through the tortuous lesion, the guide wire likely encountered resistance causing the tip of the wire to kink and ultimately separating due to manipulation against resistance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Correction: lot number, expiration date.Correction: manufacturing date.

• 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: 8930109
• Report Number: 2024168-2019-11145
• Device Sequence Number: 19384732
• Product Code: DQX
• UDI-Device Identifier: 08717648026003
• UDI-Public: 08717648026003
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 09/12/2019

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: 1001782J
• Device Lot Number: 9042471
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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: TRAILBLAZER VASCULAR SUPPORT SYSTEM; TRAILBLAZER VASCULAR SUPPORT SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 73