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

Catalog Number 2078172

Device Problems Difficult to Insert (1316); Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure of the left popliteal artery, the hi-torque command guide wire was attempted to be inserted into the non-abbott micro catheter, but could not be inserted.The wire was checked and it was noted that the distal end was peeling with some metallic material exposed.Two different non-abbott guide wires were successfully used with the micro catheter in the procedure.There was no adverse patient effect or a clinically significant delay in procedure reported.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide cath: eagle eye, other: prominent micro-catheter.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and the reported peeled polymer was confirmed.Difficulty inserting the guidewire into a catheter could not be replicated in a testing environment due to the condition of the returned device.Based on the visual and dimensional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query/review of the complaint handling database revealed no other incidents for peeling polymer and difficult to insert reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.

• Brand Name: HT COMMAND
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): BARCELONETA, PUERTO RICO REG# 3005737652; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4636945
• MDR Text Key: 5576005
• Report Number: 2024168-2015-01660
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 2078172
• Device Lot Number: 4112071
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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