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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 B1100-080
Device Problems Material Rupture (1546); Device Damaged by Another Device (2915); Torn Material (3024)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/07/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Visual inspections were performed on the returned device. The reported balloon rupture and tear was confirmed. The reported damage by the previously implanted stent could not be replicated in a testing environment as it was based on operational circumstances. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. The investigation determined the reported damage by previously implanted stent, balloon rupture, balloon tear/separation, foreign body in patient and treatment appears to be related to circumstances of the procedure. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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. 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 an armada dilatation catheter was advanced to an arterial venous (av) fistula, venous side, where a previous unspecified stent had been placed. The balloon was inflated to nominal pressure when the balloon caught on the implanted stent and the balloon shredded. The armada dilatation catheter was removed with some of the balloon still attached. A snare was used to remove other pieces of the shredded balloon; however, some pieces remained in the av fistula. There was no further treatment provided for this issue. There was no clinically significant delay. There was no additional information provided regarding this issue.
 
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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 Key6825331
MDR Text Key107626110
Report Number2024168-2017-07011
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 09/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Catalogue NumberB1100-080
Device Lot Number70320G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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: 08/28/2017 Patient Sequence Number: 1
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