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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1013465-200
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The guidewire is filed under a separate medwatch report.
 
Event Description
It was reported that the procedure was to treat an acute clot in the mildly calcified, anterior tibial artery. The 3. 0mm x 200mm x 150 cm armada 18 otw balloon dilatation catheter (bdc) was advanced without issue and was inflated for three minutes. Once deflated, the bdc was removed without resistance. However, upon removal, it was noted that the balloon had detached from the catheter and remained in the anterior tibial. The balloon was retrieved with a snare device. Although there was a delay in the procedure it did not result in significant impact to the patient. There were no adverse patient effects. Returned device analysis revealed the innermember was separated and was returned stuck on an unknown abbott guide wire. The guide wire was added as part #2 of this event. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The returned guide wire was a non-abbott guide wire. A visual inspection was performed on the retuned device. The reported balloon separation was 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. The investigation determined the reported balloon separation and subsequent damages to the inner/outer member and dispenser coil 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.
 
Event Description
Subsequent to the initially filed report, the following information was received: the returned guide wire is not an abbott guide wire. A snare device was unsuccessful in retrieving the balloon; therefore, the balloon dilation catheter (bdc) was re-wired with a non-abbott guide wire, and the balloon was retrieved. No additional information was provided.
 
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Brand NameARMADA 18 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 Key7430540
MDR Text Key105505231
Report Number2024168-2018-02780
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Catalogue Number1013465-200
Device Lot Number7112041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
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: 04/13/2018 Patient Sequence Number: 1
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