MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Catalog Number 1009664

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

It was reported that during unpackaging of the hi-torque balanced middle weight (bmw) universal ii guide wire, a black spot was noted on the guide wire tip.There was no reported patient involvement and no reported clinically significant delay in the procedure.Another hi-torque bmw universal ii guide wire was used to successfully complete the procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the complaint device was returned.The irregular appearance was confirmed.Based on the visual inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances.A query/review of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.

Manufacturer Narrative

(b)(4).

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• 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: 4738590
• MDR Text Key: 5706851
• Report Number: 2024168-2015-02432
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K072460
• 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: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• 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: 1009664
• Device Lot Number: 4112571
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2015
• 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