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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1014256-200
Device Problems Inflation Problem (1310); Difficult To Position (1467); Product Quality Problem (1506); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
(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 investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat an ectactic lesion located in the proximal femoral artery that was moderately calcified. Resistance was felt during advancement of the 5. 0x200mm armada 18 balloon catheter through the 5f sheath. The balloon catheter was retrieved with some resistance and the catheter was flushed again. It was observed that the balloon looked as if it may have already been partially inflated as the balloon wrap did not seem to be as tight as normal. On the second attempt to advance the balloon catheter it was able to advance through the sheath; however, resistance was still felt. Once the balloon progressed through to the calcified lesion, it was inflated to nominal (8atm); however, it was stated that the balloon did not feel as if it was inflating correctly which was confirmed on imaging with a section of the balloon not inflating like the rest of the balloon; therefore, it was retrieved. A 5x120mm armada 18 balloon catheter was advanced through the same sheath without difficulty and angioplasty was performed. The non-abbott 035 dilatation balloon catheter, which also required a 5f sheath for access, met resistance during advancement through the sheath; therefore, the sheath was upsized to a 6f. It was stated that there may have been a problem with the sheath. No adverse patient effects or clinically significant delay in the procedure were reported. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual and functional inspections were performed on balloon catheter. The reported difficulty to remove and unusual balloon appearance were confirmed. The reported irregular inflation and difficulty to position were unable to be confirmed. 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 was unable to determine a conclusive cause for the reported difficulty to position. Although a conclusive cause for the reported difficulty to position was not determined, the reported difficulty to remove, irregular inflation and unusual appearance appear to be related to circumstances of the procedure as it is likely the resistance and manipulation during the multiple advancements of the balloon catheter, the balloon folds became loose resulting in the reported difficulty to remove during retraction causing the noted wrinkles on the proximal end of the balloon. Additionally, the reported anatomical conditions likely resulted in the irregular inflation issue. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand NameARMADA 18 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7631695
MDR Text Key112308255
Report Number2024168-2018-04886
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Catalogue Number1014256-200
Device Lot Number8010941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/22/2018 Patient Sequence Number: 1
Treatment
CORDIS 11 CM 5F SHEATH
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