MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE PROGRESS 120 GUIDE WIRE

Catalog Number	1011844
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was 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 identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Manipulation of the guide wire resulted in the reported tip detachment.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, heavily tortuous, 100% stenosis in the chronic total occlusion (cto) in the distal right coronary artery (rca).The progress 120 guide wire was advanced to the distal rca; however, the guide wire tip became stuck in the calcified anatomy.During withdrawal of the guide wire from the anatomy, resistance was met with the anatomy and the distal 3 cm of the tip became separated.The separated tip remains stuck in the calcium.A second progress 120 guide wire was inserted, but the physician decided not to proceed to avoid a significant delay in the procedure.There was no issue with the second progress 120 guide wire.The procedure was aborted.There was no adverse patient effect.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE PROGRESS 120 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: 7338667
• Report Number: 2024168-2018-01826
• Device Sequence Number: 18967371
• Product Code: DQX
• UDI-Device Identifier: 08717648138003
• UDI-Public: 08717648138003
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

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: 07/31/2019
• Device Catalogue Number: 1011844
• Device Lot Number: 7080471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: HEARTRAIL AL1
• Outcome Attributed to Adverse Event: Other