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

Catalog Number 821985401

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: command, winn40, guide catheter: brite-tip.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat an occluded lesion in the popliteal vessel with mild tortuosity and heavy calcification.The 2.0 x 60 mm fox sv balloon catheter was advanced without issue and inflated to an unknown pressure that was close to rated burst pressure.The lesion was fully expanded and there was no issue with inflation.When negative pressure was applied, the needle of the inflation device dropped so the physician suspected shaft damage.After removal, it was observed that there a crack (like a hole) at the distal shaft, 15-20cm proximal from the tip, outside of the anatomy.The procedure was completed without any issue.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: unique device identifier (udi): (b)(4).The device was returned and the reported leak and hole in the shaft was confirmed.Based on visual and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that the leak was due to the noted tear in the shaft.A conclusive cause for the tear 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.

• 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: 5011723
• MDR Text Key: 24282854
• Report Number: 2024168-2015-04717
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 821985401
• Device Lot Number: 835774
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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: 70 YR
• Patient Weight: 50