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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 B1120-060
Device Problems Off-Label Use; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method
Event Date 09/28/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). Evaluation summary: visual analysis was performed on the returned device. The reported balloon rupture and separation was confirmed. It should be noted that the armada 35 instruction for use warns: inflation in excess of the rated burst pressure may cause the balloon to rupture. Additionally, it was reported that the armada 35 was being used to treat the cephalic vein. It should be noted that the ifu states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature. It could not be determined if using off-label contributed to the reported difficulties. 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 history identified no other incidents from this lot. The investigation determined that the reported difficulties were likely due to case circumstances. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

 
Event Description

It was reported that during a procedure of the severely stenosed cephalic vein using a radial venous access, the 12 x 60 mm armada balloon dilatation catheter (bdc) was being inflated. During the first inflation above rated burst pressure (rbp) the balloon ruptured and detached. Several attempts using different access sites and sheath changes were unsuccessful; eventually, the balloon fragment was snared and removed from the vein. Although the procedure time was extended by approximately 2 hours, there was no clinical significance to the patient who remained stable throughout the procedure. There was no reported adverse patient sequela. No additional information was provided.

 
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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 Key7986994
Report Number2024168-2018-08053
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 10/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device Catalogue NumberB1120-060
Device LOT Number60409G1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/11/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/19/2018 Patient Sequence Number: 1
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