MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

Catalog Number	1009660J
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
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 was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the hi-torque balance middleweight universal guide wire kinked and then separated at the transition of the hypotube prior to entering an unspecified guide wire introducer.The device was not used and there was no patient involvement.A non-abbott guide wire was used to successfully complete the procedure.140 unused/sterile guide wires from two different lot numbers will be returning, and two devices for each lot number were opened and manipulated by the physician, which resulted in the same kink and separation.There were no adverse patient effects and no clinically significant delay in the procedure.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 of the returned guide wire, and the reported separation and kink 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.Based on the reported information and review of similar incident(s) there is no indication of a lot specific product quality issue.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.The investigation determined the reported separation appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that inadvertent manipulation during advancement through the guide wire introducer, the guide wire bent and kinked resulting in the guide wire separation at the hypotube joint.Based on the photos of the returned analysis, the fracture face of the separation appears to be oval shaped as if kinked prior to separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9370724
• Report Number: 2024168-2019-13876
• Device Sequence Number: 2238150
• Product Code: DQX
• UDI-Device Identifier: 08717648065866
• UDI-Public: 08717648065866
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K101011
• 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): 12/20/2019

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: 07/31/2021
• Device Catalogue Number: 1009660J
• Device Lot Number: 9080671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1