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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 B2120-060
Device Problems Entrapment of Device (1212); Material Rupture (1546); Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 03/02/2021
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional armada 35 device referenced is filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat a common iliac artery.A 12x40mm armada 35 balloon was advanced to the lesion without resistance.Once at the lesion, the balloon was inflated once at 3-4 atmospheres (atm) and ruptured circumferentially.The device was withdrawn without issue.Then a 12x60mm armada 35 balloon was advanced to the lesion without resistance.Once at the lesion, the balloon was inflated once at 3-4 atmospheres (atm) and ruptured circumferentially.The device was attempted to be removed but met resistance with the anatomy and could not be removed completely.Therefore surgical intervention was performed to successfully remove the device.A non-abbott balloon was used to successfully complete the procedure.There was a clinically significant delay reported.No additional information was provided.
 
Event Description
It was reported that the procedure was to treat a common iliac artery.A 12x40mm armada 35 balloon was advanced to the lesion without resistance.Once at the lesion, the balloon was inflated once at 3-4 atmospheres (atm) and ruptured circumferentially.The device was withdrawn without issue.Then a 12x60mm armada 35 balloon was advanced to the lesion without resistance.Once at the lesion, the balloon was inflated once at 3-4 atmospheres (atm) and ruptured circumferentially.The device was attempted to be removed but met resistance with the anatomy and could not be removed completely.Therefore surgical intervention was performed to successfully remove the device.A non-abbott balloon was used to successfully complete the procedure.There was a clinically significant delay reported.Subsequent to the initially filed mdr, additional information received from the account confirms that during removal the 12x60mm armada 35 balloon became separated [the balloon was separated at the same location as the ruptures noted] due to the resistance.Surgical intervention removed the remaining of the device and nothing was left in the anatomy.No additional information was provided.
 
Manufacturer Narrative
A visual analysis and scanning electron microscopy (sem) analysis were performed on the returned device.The reported balloon rupture and separation was confirmed.The difficulty removing (entrapment) was not tested due to the condition of the device.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 complaints reported from this lot.Based on the reported information, evaluation of the returned unit and sem analysis the investigation determined that the reported difficulties and subsequent patient effects were likely due to circumstances of the procedure.It is likely that the balloon rupture was the result of interaction with the heavily calcified lesion.In addition, the resistance (entrapment) noted during removal and separation of the balloon were likely the result of the ruptured balloon material catching on the introducer sheath or anatomy during the attempt to remove.The additional damages noted to the returned unit likely occurred during the difficulties encountered while removing the ruptured/separated device from the anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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Brand Name
ARMADA 35 PTA CATHETER
Type of Device
PERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11578883
MDR Text Key242662423
Report Number2024168-2021-02451
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08717648155567
UDI-Public08717648155567
Combination Product (y/n)N
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2023
Device Model NumberB2120-060
Device Catalogue NumberB2120-060
Device Lot Number00515G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2021
Date Manufacturer Received05/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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