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

Catalog Number UNK HT COMMAND

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the tibro peroneal trunk.When the atherectomy catheter was being advanced over the command guide wire in the patient anatomy it became stuck on the guide wire.As the atherectomy catheter could not be removed from the guide wire both devices were removed together from the anatomy.When the guide wire was removed from the atherectomy catheter the after use the tip was observed to be torn.No adverse patient effects or clinically significant delay in the procedure were reported.After removal of the devices the case was successfully completed with balloon angioplasty.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported torn material was confirmed although difficulty positioning and removing the guide wire could not be replicated in a testing environment as it was based on operational circumstances of the procedure.A review of the lot history record and complaint history could not be conducted, because the part and lot numbers were not provided.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.

• Brand Name: HT COMMAND
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5698423
• MDR Text Key: 46761090
• Report Number: 2024168-2016-03588
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK HT COMMAND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1