MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE FLOPPY II EXTRA SUPPORT GUIDE WIRE WITH MICROGLIDE COATING

Model Number	22359M-901
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Attachment: medwatch report# mw5110202.
Event or Problem Description
User facility medwatch received which states: abbott hi torque floppy extra support 0.14x30cm.Fda safety report id# (b)(4).The following additional information was received from the account: the procedure was an impella assisted percutaneous coronary intervention and the hi torque extra support guide wire tip fractured in the distal ramus branch and no attempts were reported to remove the tip.There were no reported adverse patient sequela.The patient was discharged to home.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the lot number was not provided.As there was no reported damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the anatomy/other devices and/or inadvertent mishandling resulted in the reported material separation.Reportedly, no attempts were reported to remove the tip.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3 - device available for eval updated from 'yes' to 'no'.
Event or Problem Description
N/a.

• Brand Name: HI-TORQUE FLOPPY II EXTRA SUPPORT GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15015519
• Report Number: 2024168-2022-07701
• Device Sequence Number: 14082710
• Product Code: DQX
• UDI-Device Identifier: 08717648080326
• UDI-Public: 08717648080326
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K913353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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 Model Number: 22359M-901
• Device Catalogue Number: 22359M-901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 93 KG