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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number A1025-120
Device Problems Partial Blockage; Difficult to Insert; Device Contamination with Chemical or Other Material
Event Date 01/12/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 the armada 14 balloon dilatation catheter could not be loaded over the guide wire due to an orange plastic spike observed inside the guide wire lumen of the complaint device, inhibiting the insertion of a wire. The device was not used. A second armada 14 balloon catheter was used to successfully complete the procedure. There were no adverse patient effects. There was no clinically significant delay. No additional information was provided.

 
Manufacturer Narrative

(b)(4). The device was returned for evaluation and the reported difficulty to insert/blockage was confirmed. The reported foreign material was not confirmed. Based on visual, dimensional, and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling. A conclusive cause for the damage that caused the insertion difficulty could not be determined. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no other incidents from this lot. Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.

 
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Brand NameARMADA 14 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)
CLONMEL, IRELAND REG# 9616693
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 Key5418272
Report Number2024168-2016-00700
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/26/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/08/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2018
Device Catalogue NumberA1025-120
Device LOT Number5072141
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/12/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2015
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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