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

Model Number	1011880
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.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.
Event or Problem Description
It was reported that a balance middleweight (bmw) elite guide wire was being introduced into an unspecified guiding catheter when the guide wire core separated.The separated guide wire was removed along with the guiding catheter.A non-abbott guide wire was 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.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported separation was confirmed.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 incidents reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported core separation appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that manipulation and/or inadvertent mishandling of the guide wire during advancement through the guiding catheter, the wire core became bent or kinked resulting in the reported separation.The wire core fractured faces at the separation were ovalled as if kinked or bent prior to separation.The noted teflon coating damage likely occurred during retraction through the torque device used in the procedure or during packing for returned analysis.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 ELITE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9495263
• Report Number: 2024168-2019-14744
• Device Sequence Number: 2086475
• Product Code: DQX
• UDI-Device Identifier: 08717648144783
• UDI-Public: 08717648144783
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103101
• 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): 03/19/2020

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: 05/31/2021
• Device Model Number: 1011880
• Device Catalogue Number: 1011880
• Device Lot Number: 9061261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1