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

Catalog Number	2078172
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2017
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.Concomitant products: dilatation catheter: coyote, guide catheter: destination, the device was not returned for evaluation.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.The investigation was unable to determine a conclusive cause for the reported difficulties.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 chronic total occlusion located below the knee.A non-abbott atherectomy catheter crossed the lesion and then a 190 cm ht command guide wire was advanced through the atherectomy catheter up to the lesion.Then the guide wire met resistance with a non-abbott balloon catheter when the catheter was being advanced to the lesion.Thus both devices were removed from the anatomy and part of the guide wire was found to be separated inside the anatomy.It is unknown how the separated portion of the guide wire was removed from the anatomy.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HT COMMAND
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6664755
• Report Number: 2024168-2017-05320
• Device Sequence Number: 1972790
• Product Code: DQX
• UDI-Device Identifier: 08717648176654
• UDI-Public: (01)08717648176654(17)190228(10)7030771
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2017

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: 02/28/2019
• Device Catalogue Number: 2078172
• Device Lot Number: 7030771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/23/2017
• 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: SEE H10 FOR CONCOMITANT MEDICAL DEVICES
• Outcome Attributed to Adverse Event: Required Intervention