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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 B1120-060
Device Problems Break (1069); Peeled/Delaminated (1454); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2020
Event Type  Malfunction  
Manufacturer Narrative

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 the procedure was to treat a lesion in the iliac artery. The 12mm x 60mm armada 35 balloon dilatation catheter (bdc), was used without issue; however, during removal, resistance was felt with the 6f non-abbott introducer sheath. The balloon shredded inside of the introducer sheath and the tip of the catheter broke but did not separate in two pieces. The procedure was complete at this time, the bdc and introducer sheath were removed as a single unit. There were no adverse patient effects and there was no clinically significant delay during the procedure. No additional information was provided.

 
Manufacturer Narrative

The device was not returned for analysis. 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 of the reported lot revealed no other complaints. Based on the information provided, a definitive cause for the reported difficulties could not be determined. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. Device not available for evaluation.

 
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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 Key9885018
MDR Text Key185097755
Report Number2024168-2020-02972
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2021
Device MODEL NumberB1120-060
Device Catalogue NumberB1120-060
Device LOT Number70821G1
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 Received04/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/21/2017
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: 03/26/2020 Patient Sequence Number: 1
Treatment
6F PRELUDE INTRODUCER SHEATH
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