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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 B1100-020
Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device is expected to be returned for evaluation. 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 the left superficial femoral artery. A 10 x 20 mm armada 35 balloon dilatation catheter (bdc) was used; however, the device met resistance with an unspecified guide wire during removal. Therefore, the bdc was removed independently using some extra force. When it was removed, it was noted that the tip was kinked. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual, dimensional and functional inspections were performed on the returned device. The reported kinked tip and difficulty to remove were unable to be confirmed as the proxy guide wire was advanced and removed without any issues or kinks noted. 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 similar incidents reported from this lot. The investigation was unable to determine a conclusive cause for the reported difficulties. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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
MDR Report Key8055956
MDR Text Key127274842
Report Number2024168-2018-08646
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue NumberB1100-020
Device Lot Number60523G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

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