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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 B1100-040
Device Problems Off-Label Use; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method
Event Date 10/11/2018
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). The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.

 
Event Description

It was reported that the procedure was to treat a fistula in the cephalic vein. A 10 x 40 mm armada 35 balloon dilatation catheter (bdc) was used and did not meet any resistance during advancement. However, the balloon was inflated once and ruptured at 14 atmospheres. Additionally, the balloon material separated in the anatomy; therefore, it was retrieved via a puncture that was made in the cephalic vein with the use of a femoral and procedural sheath. There was no adverse patient sequela reported. 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 Key8029216
Report Number2024168-2018-08358
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB1100-040
Device LOT Number80510G1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/02/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2018
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: 11/01/2018 Patient Sequence Number: 1
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