MAUDE Adverse Event Report: AV-TEMECULA-CT HT POWERTURN; GUIDE WIRE

Catalog Number	1044594
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	02/05/2019
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 and complaint history could not be conducted because the lot number was not provided.The reported patient effect of dissection is listed in the hi-torque guide wires instructions for use as a known patient effect of coronary stenting procedures.The investigation determined a conclusive cause for the reported device operates differently than expected cannot be determined.Additionally, it is possible the reported difficulties resulted in the reported dissection; however, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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 lesion located in the right coronary artery.While advancing the hi-torque powerturn guide wire to the vessel, the wire jumped forward, straightening the vessel and dissecting it near the proximal right ostial.Patient was sent to surgery for successful repair.The patient was reported doing fine after surgery.No additional information was provided.

• Brand Name: HT POWERTURN
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8372173
• Report Number: 2024168-2019-01483
• Device Sequence Number: 11095948
• Product Code: DQX
• UDI-Device Identifier: 08717648173974
• UDI-Public: 08717648173974
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K112957
• 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): 02/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1044594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/26/2019
• 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: Hospitalization; Required Intervention