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

Catalog Number 83173-02

Device Problems Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was to treat an unspecified area of the profunda artery.A 4.0 x 150 fox sv balloon catheter was advanced to the lesion; however, under angiography it was noted that there were no markers visible.The device was removed from the anatomy to reveal the balloon and distal shaft with the markers was missing.Angiography revealed there was no separated portion of the catheter in the anatomy.There was no resistance removing the device from the packaging or removing the protective sheath.The device was prepped before use by flushing the guide wire lumen.There was no resistance advancing the device to the lesion.A non-abbott balloon was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported separation was confirmed.Based on visual analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.A conclusive cause for the separated shaft could not be determined.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 handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.(b)(4).

• Brand Name: FOX SV 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: 5238220
• MDR Text Key: 31740231
• Report Number: 2024168-2015-07042
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 83173-02
• Device Lot Number: 853463
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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
• Patient Age: 50 YR
• Patient Weight: 45