MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE PILOT GUIDE WIRE

Catalog Number	1010481-H
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned.A visual, dimensional and functional inspections were performed.The reported difficulty to insert/position the balloon catheter over the guide wire was unable to be confirmed due to the guide wire damage.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 reported from this lot.Based on the reported information, it is likely that during advancement of the guide wire through the heavily tortuous, mildly calcified, 90% stenosed anatomy, the polymer coating became damaged (peeled, bunched and detached) resulting in the difficulty to position the balloon catheter over the guide wire.There was no damage noted to the guide wire during the inspection prior to use.There is no indication of a product quality issue with respect to design, manufacture or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the heavily tortuous, mildly calcified, 90% stenosed mid right coronary artery.An allstar guide wire was removed from the dispenser coil without resistance and it was noted that the guide wire coils were stretched.The coils and core of the guide wire did not separate.A non-abbott guide wire was used successfully.A.014 hi-torque pilot 150 guide wire was advanced in the artery; however, unusual resistance was felt while advancing an unspecified non-compliant balloon catheter over the guide wire.The pilot 150 guide wire was removed.An unspecified 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.Returned device analysis identified a separated portion of polymer that was not reportedly noted.No portion of the device remains in the patient.No additional information was provided.

• Brand Name: HI-TORQUE PILOT GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 9173365
• Report Number: 2024168-2019-05578
• Device Sequence Number: 14034214
• Product Code: DQX
• UDI-Device Identifier: 08717648073878
• UDI-Public: 08717648073878
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: 02/29/2020
• Device Catalogue Number: 1010481-H
• Device Lot Number: 8030671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1