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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B2040-040
Device Problems Leak / Splash; Physical Resistance
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.

 
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Brand NameARMADA 35 PTA CATHETER
Type of DevicePERIPHERAL 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 Key4771905
Report Number2024168-2015-02716
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/14/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2016
Device Catalogue NumberB2040-040
Device LOT Number30109G1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/04/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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