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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 B2060-080
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2018
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 customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed to treat a heavily calcified, subtotal occlusion lesions in the iliac artery. A 5. 0x80 mm armada dilated the right iliac artery, followed by the 6. 0x80 armada at the same artery. The 6. 0x80 armada was inflated to 16 atmospheres initially and then ruptured with the third or fourth inflation at 20 atmospheres. It had been at a tight angle where the balloon was halfway in the left and halfway in the right side, so when it ruptured, the balloon split in half. The distal segment had wrapped around the guide wire and remained on the guide wire. There was no distal embolization of the balloon. Attempts to percutaneously remove the guide wire were made, including use of a snare, but these attempts were not successful. A surgeon was consulted who performed a mini cut-down and surgically removed the wire and separated balloon. The balloon was still wrapped around the wire. The patient tolerated the surgery and the distal blood flow had been improved from the balloon angioplasty with the armadas. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The product was not returned to abbott vascular for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Review of the complaint history identified no other similar incidents reported from this lot. It should be noted that the device instructions for use states: inflation in excess of the rated burst pressure (rbp) may cause the balloon to rupture. The investigation determined the balloon rupture appears to be related to the user error as the balloon was inflated above rbp. The reported balloon separation and difficult to remove are related to circumstances of the procedure. 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
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 Key7535740
MDR Text Key108981576
Report Number2024168-2018-03832
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111899
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 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue NumberB2060-080
Device Lot Number70825G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2017
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: 05/22/2018 Patient Sequence Number: 1
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