MAUDE Adverse Event Report: AV-TEMECULA-CT FOXCROSS PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 10309-40

Device Problems Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Unique device identifier (udi): (b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The investigation determined the reported complaint appears to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents from this lot.It should be noted that the fox cross information for use section: use prior to use by date.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the sales representative noted the foxcross was found missing from inventory in (b)(6) 2015.The foxcross was used (b)(6) 2015.In (b)(6) 2016 after an invoice was received from the hospital, it was noted that this foxcross had expired on 10/31/2015.There were no adverse patient effects reported.No additional information was provided.

• Brand Name: FOXCROSS PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): BERINGEN, SWITZERLAND REG# 9710478; 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: 5408910
• MDR Text Key: 37724692
• Report Number: 2024168-2016-00629
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K102705
• 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
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 10309-40
• Device Lot Number: 779591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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