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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 A2020-120
Device Problems Inflation Problem (1310); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. Use after damage. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the peripheral artery with heavy calcification and heavy tortuosity. A 2. 0 x 120 mm armada 14 balloon catheter advanced to the target lesion when the balloon could not be inflated and a balloon tear was observed. Reportedly, it was noticed that the balloon was damaged prior to use. The procedure was successfully completed with a non-abbott balloon catheter and an unspecified absolute pro stent. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: a visual and functional inspection was performed on the retuned device. The reported inflation issue, material rupture and balloon damage were confirmed. 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. It should be noted that armada 14 catheter, instructions for use (ifu) states: carefully inspect the catheter prior to use to verify that it has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. In this case, it is likely the ifu deviation contributed to the reported difficulties of balloon rupture and deflation issue. The investigation determined that the reported difficulties of device used after rupture and balloon rupture appear to be related to user error as the device was used after damages were noted. The reported/noted inflation issue, balloon damage, inner/outer member and shaft damages appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect 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 Key7494205
MDR Text Key107705054
Report Number2024168-2018-03371
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
K102705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue NumberA2020-120
Device Lot Number7012541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2017
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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