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

Catalog Number 2078175

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the heavily calcified, mildly tortuous anterior tibial artery.There were no issues noted during preparation of the guide wire prior to use.There was no resistance felt during advancement of the guide wire to the lesion; however, the guide wire felt like it was sticking inside the sheath.It was removed and inspected and the polymer was observed to be lifting of the guide wire.It was confirmed that none of the coating remained in the patient.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4): evaluation summary: the device was returned for analysis.Visual and dimensional inspections were performed on the returned device.The damaged polymer was confirmed.The difficult to position could not be replicated in a testing environment due to the conditions of the returned device.It is possible the guide wire was not sufficiently wetted prior to use, therefore the hydrophilic coating was not properly activated, which resulted in the reported resistance with the introducer sheath; however this could not be confirmed.Further manipulation as resistance was encountered would have resulted in the noted polymer damages.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 from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to position however the damaged polymer appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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): BARCELONETA, PUERTO RICO REG# 3005737652; 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: 6187718
• MDR Text Key: 63193065
• Report Number: 2024168-2016-09020
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 2078175
• Device Lot Number: 6081972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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