MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number B2040-040

Device Problems Leak/Splash (1354); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the superficial femoral artery with heavy tortuosity.The 4.0 x 40 mm armada 35 balloon catheter was advanced to the lesion for pre-dilatation.Significant resistance was noted due to the tortuosity during advancement.The balloon was inflated, but could not reach nominal pressure due to a leak noted on the shaft.It was believed that the lesion was opened enough and the 6.0 x 40 mm absolute pro stent delivery system (sds) was advanced.Significant resistance was noted due to the tortuosity during advancement, and before the sds reached the lesion, it became stuck on the guide wire, and could not be removed.The sds and guide wire were removed as a unit.The vessel was re-wired and the 6.0 x 30 mm absolute pro sds was advanced.Significant resistance was noted again with the anatomy.The stent was deployed successfully; however, after deployment it was noted that the mid stent was fractured.A non-abbott covered stent was deployed for treatment of the stent fracture.At this point, the procedure was completed, and it was confirmed that there were no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 6.0 x 40 mm absolute pro and the 6.0 x 30 mm absolute pro stent delivery systems referenced are being filed under separate medwatch mfr numbers.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The returned device analysis identified a leak from the strain relief tubing near the hub, which was found when the balloon catheter was pressurized.A search of the complaint handling database was performed and no other incidents were identified from this lot for hub leaking issues.Based on an expanded investigation, a product issue related to leakage at the hub was identified.The event was possibly related to hub assembly during manufacturing.Further assessment of this issue per site operating procedures was performed.These devices will continue to be monitored.

• Brand Name: ARMADA 35 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): EL COYOL, COSTA RICA REG# 3009031392; 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: 4771905
• MDR Text Key: 5796742
• Report Number: 2024168-2015-02716
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: B2040-040
• Device Lot Number: 30109G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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