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

Catalog Number	1010482-H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing for this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: dilatation catheter: otw 1.5x20 mm trek, 1.20x12 mm trek.Guide catheter: turnpike spiral, guidezilla, 7 french hockey stick 5h.The device was not returned for evaluation.The electronic lot history record (lhr) review and similar incident query for this product were not performed because the lot number was not reported and the product was not returned for analysis.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of dissection is listed in the hi-torque guide wires instructions for use as a known patient effect associated with use of this device.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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 to treat a chronic total occlusion in the right coronary artery (rca).Multiple guide wires were attempted to cross, including a whisper extra support and pilot 50 guide wire, but were unable to cross the chronic total occlusion.A pilot 200 guide wire was successful in crossing over using a mini support catheter.The pilot guide wire appeared to be in the true vessel lumen, but the support catheter was unable to advance further.The support catheter was exchanged for a spiral catheter, which was able to be advanced to the mid rca.Angioplasty was performed in the mid rca with a 1.2x12 and a 1.5x20 mm trek, but these could not be advanced past the mid rca.There was no significant change in blood flow and a dissection was noted in the distal rca.The procedure was completed.No treatment was given for the dissection.The patient remained hemodynamically stable and was asymptomatic through out 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: 8527478
• Report Number: 2024168-2019-03051
• Device Sequence Number: 14049473
• Product Code: DQX
• UDI-Device Identifier: 08717648073892
• UDI-Public: 08717648073892
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1010482-H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 04/18/2019
• 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: 69 YR
• Patient Weight: 77