MAUDE Adverse Event Report: ABBOTT VASCULAR 014 IRONMAN MICRO; GUIDE WIRE

Model Number	1001311
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 this was a percutaneous intervention to treat the left superficial femoral artery (sfa).The 014 iron man guide wire was advanced to the heavily calcified sfa and balloon angioplasty was performed.The procedure was completed.After removal of the iron man guide wire, it was noted that the tip of the guide wire had separated.The separated segment was successfully removed via a snare device.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 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 tip separation appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement, the guide wire likely encountered resistance with the heavily calcified anatomy likely causing the tip to kink.Manipulation during retraction likely resulted in the core and coil separation and subsequent coil stretch damage.The reported treatment appears to be related to the operational context of the procedure the separated segment of the guide wire removed using a snare catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: 014 IRONMAN MICRO
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10543893
• Report Number: 2024168-2020-07772
• Device Sequence Number: 14255146
• Product Code: DQX
• UDI-Device Identifier: 08717648013652
• UDI-Public: 08717648013652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K963702
• 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): 10/02/2020

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: 02/28/2022
• Device Model Number: 1001311
• Device Catalogue Number: 1001311
• Device Lot Number: 0032461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention