MAUDE Adverse Event Report: ABBOTT VASCULAR HI TORQUE SUPRA CORE 35; GUIDE WIRE

Model Number	1002703-02
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was an endovascular aneurysm repair (evar) in the abdominal aorta.The supracore guide wire was used in the procedure and during removal of a balloon dilatation catheter, some resistance was noted with the guide wire as there was a rough spot.When removed from the anatomy, it was noted that there was a portion of the wire with missing teflon.It was also noted that this portion of exposed wire appeared to have a bump or notch.The physician does not believe that any portion remained in the patient and no intervention was performed to remove anything.There were no reported adverse patient effects; however, as the portion is missing and cannot be seen under fluoroscopy it is possible it remained in the patient.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional and functional inspections were performed on the returned guide wire, and the reported difficult to remove and irregular texture were confirmed.The reported material split, cut, torn or portion with missing teflon was unable to be 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 similar incidents and/or complaints reported from this lot.The investigation determined that the reported difficulties appears to be related to operational circumstances of the procedure.It is likely that manipulation of the guide wire during advancement and/or use, the intermediate/butt solder joint became damaged causing the coils to unravel causing the reported irregular texture, and the difficulty to remove during retraction and subsequent noted damages to the coils.Based on the returned analysis of the wire, there does not appear to be any missing portion of teflon on the wire as reported.Based on the design of the guide wire, only the proximal core and proximal coil ribbon are to be coated with teflon, then are soldered together at the intermediate/butt solder joint.The noted teflon coating scratches and likely occurred during retraction through the torque device used in the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI TORQUE SUPRA CORE 35
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9548859
• Report Number: 2024168-2020-00240
• Device Sequence Number: 2375048
• Product Code: DQX
• UDI-Device Identifier: 08717648033001
• UDI-Public: 08717648033001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K980119
• 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): 03/03/2020

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: 05/31/2021
• Device Model Number: 1002703-02
• Device Catalogue Number: 1002703-02
• Device Lot Number: 9061761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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: Other
• Patient Age: 80 YR
• Patient Weight: 77