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

Catalog Number	2078174
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual inspections were performed on the returned device.The reported irregular appearance was confirmed.The distal polymer coating was sporadically scraped and torn exposing the coil.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 similar incidents from this lot.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.The investigation was unable to determine a conclusive cause for the reported difficulties.
Event or Problem Description
It was reported that the 190 cm ht command guide wire was unpacked and flushed with saline without issue.Prior to insertion into the patient anatomy, a portion of the tip was noticed to be uncoated.The guide wire was not used on the patient.The procedure was successfully completed with another guide wire and the patient is doing well.There was no clinically significant delay in the procedure.No additional information was provided.Returned device analysis revealed the polymer coating on the guide wire was torn.

• 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: 5922358
• Report Number: 2024168-2016-05870
• Device Sequence Number: 472284
• Product Code: DQX
• UDI-Device Identifier: 08717648176678
• UDI-Public: (01)08717648176678(17)161031(10)4111071
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103101
• 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): 09/01/2016

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: 10/31/2016
• Device Catalogue Number: 2078174
• Device Lot Number: 4111071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2016
• Initial Report FDA Received Date: 09/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1