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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number B1070-040
Device Problems Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2020
Event Type  Malfunction  
Manufacturer Narrative

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. Additionally, a review of the complaint history identified no other similar incidents reported from this lot. The investigation determined that the reported issue regarding difficult to advance, and material rupture appears to be related to operational circumstances of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling.

 
Event Description

It was reported that the procedure was to treat a mildly tortuous, mildly calcified axillary artery that was 70% stenosed. A 7. 0x40mm armada 35 was attempted to dilate the lesion but the balloon ruptured at 15 atmospheres at the second inflation. It was noted that resistance was met during advancement with anatomy. Another unspecified balloon was used to complete the procedure. There were no adverse patient effects and no clinically significant delay. No additional information was provided.

 
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Brand NameARMADA 35 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10020677
MDR Text Key189838397
Report Number2024168-2020-04057
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeTW
PMA/PMN NumberK111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 05/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberB1070-040
Device Catalogue NumberB1070-040
Device LOT Number70809G1
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 Received04/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/09/2017
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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