MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WHISPER MS GUIDE WIRE

Model Number	1005359H
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.Sus voluntary event report (mw5094085).
Event or Problem Description
User facility medwatch report received that states: patient came into hospital for urgent limb salvage case found to have in stent re-stenosis in common femoral artery.The entry was made on the right side with a cross over the left common femoral / iliac artery where the existing stent was occluded.At the end of the procedure when attempt was made to remove the wire and the supporting catheter the wire would not release from its position.An attempt was made to place the catheter over the wire and pull back the system but this was also unsuccessful.After several attempts were made the wire and catheter released.It was noted by the scrub tech that the end of the wire had broken off and under fluoroscopy was noted to be retained in the vessel noted above.The doctor was made aware.No attempt at retrieval was made at that time.Fda safety report id# (b)(4).No additional information was provided.
Additional Manufacturer Narrative
The device was not returned to abbott vascular 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 incidents and/or complaints 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 difficulty to remove and tip separations appear to be related to operational circumstances of the procedure.Although limited information was provided, it is likely that during the procedure the guide wire likely became kink against the anatomy and/or other devices used causing the difficulty to remove.Manipulation against resistance likely resulted in the tip separation.The reported treatment appears to be related to the operational context of the procedure as no attempts were made to remove the separated tip.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Sus voluntary event report (mw5094085) (b)(4).

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10045539
• Report Number: 2024168-2020-04241
• Device Sequence Number: 16760278
• Product Code: DQX
• UDI-Device Identifier: 08717648037825
• UDI-Public: 08717648037825
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2020

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: 09/30/2020
• Device Model Number: 1005359H
• Device Catalogue Number: 1005359H
• Device Lot Number: 8102371
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 07/20/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 05/29/2020; 07/24/2020
• 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: CATHETER: QUICK CROSS; SHEATH: 6FR TERUMO
• Outcome Attributed to Adverse Event: Hospitalization