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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 B1100-080
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative

Event date is estimated. 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, the reported balloon rupture was likely due to circumstances of the procedure. It is likely that the difficulty advancing, and balloon rupture were the result of interaction with the previously placed stents. Additionally, it is likely that during removal, the ruptured balloon material caught on the introducer sheath, resulting in difficulty removing and separation of the balloon. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. Attachment: medsun report number: 2300200000-2020-8002.

 
Event Description

User facility medwatch report received that states: "patient brought to ir, accompanied by crna and rn, for an outpatient scheduled fistulogram with possible intervention. An angioplasty was attempted. The balloon used burst and became lodged in patient. After unsuccessful attempts were made to retrieve balloon, the plan was for the patient to be taken to or to have balloon removed surgically. Patient was removed from procedure table and taken to post op. After consulting additional physicians, the decision was made to bring the patient back to ir for a different approach. The patient returned to ir accompanied by crna and rn. After changing the approach the femoral access, the balloon was retrieved using a snare. When questioning staff, it was noted that there were stents in the patient that might have snagged the balloon, however it is unclear what the root cause was. Unfortunately, due to the condition of the balloon, staff discarded the device post-op. There was no harm to the patient, and they were discharged same day. " 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 Key9897277
MDR Text Key189471595
Report Number2024168-2020-03067
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberB1100-080
Device Catalogue NumberB1100-080
Device LOT Number90725G1
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 Received07/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/25/2019
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: 03/30/2020 Patient Sequence Number: 1
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