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

Catalog Number	1010480-HJ
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device not returned 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 did not indicate a lot specific quality issue.As there were no problems advancing the unspecified 3.5x24 mm stent delivery system over the guide wire after the unspecified 2.0x15 mm balloon dilatation catheter was used, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely interaction with the balloon dilatation catheter resulted in the reported difficulty to position and the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the mid left anterior descending coronary artery with 95% stenosis.A 014 hi-torque pilot guidewire was advanced to the lesion.An unspecified 2.0x15 mm semi compliant balloon dilatation catheter (bdc) was advanced to the lesion with resistance on the guidewire.An attempt to move the guidewire while the balloon was inflated was made.The bdc was removed independently with resistance from the guidewire.The procedure was successfully completed by deploying an unspecified 3.5x24 mm drug eluting stent using the same guidewire.There were no problems advancing the stent delivery system over the guidewire.There were no adverse patient effects and no reported clinically significant delay in the procedure.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: 7870221
• Report Number: 2024168-2018-07118
• Device Sequence Number: 2348898
• Product Code: DQX
• UDI-Device Identifier: 08717648073861
• UDI-Public: 08717648073861
• 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,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2018

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: 1010480-HJ
• Device Lot Number: 8030171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1