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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the cardiology fellow that was assisting with the removal of the intra-aortic balloon (iab).The fellow stated that they were attempting a planned removal of the iab.They were pulling the catheter and the sheath together as recommended.He pulled the catheter until it engaged the sheath, and then pulled them together.The sheath was fully removed, but they could not get the tail of the iab to come out.They attempted to manually withdraw air from the balloon with a syringe and were able to pull back 10cc before getting resistance.They were still unable to remove at this point.They called the hotline to discuss any further action prior to surgically removing the iab.As a result, the doctor stated that they are going to proceed with surgical removal.They were able to successfully remove the iab surgically.There were no other complications or injuries to the patient, and the patient is doing well in the icu.The iab was discarded in the or, and they could not see any report of a clot or kinking to the balloon.
 
Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab removal difficulty is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
 
Event Description
It was reported by the cardiology fellow that was assisting with the removal of the intra-aortic balloon (iab).The fellow stated that they were attempting a planned removal of the iab.They were pulling the catheter and the sheath together as recommended.He pulled the catheter until it engaged the sheath, and then pulled them together.The sheath was fully removed, but they could not get the tail of the iab to come out.They attempted to manually withdraw air from the balloon with a syringe and were able to pull back 10cc before getting resistance.They were still unable to remove at this point.They called the hotline to discuss any further action prior to surgically removing the iab.As a result, the doctor stated that they are going to proceed with surgical removal.They were able to successfully remove the iab surgically.There were no other complications or injuries to the patient, and the patient is doing well in the icu.The iab was discarded in the or, and they could not see any report of a clot or kinking to the balloon.
 
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Brand Name
FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8065862
MDR Text Key127053617
Report Number3010532612-2018-00336
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902034724
UDI-Public00801902034724
Combination Product (y/n)N
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17B0008
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/19/2018
Initial Date FDA Received11/13/2018
Supplement Dates Manufacturer Received12/12/2018
Supplement Dates FDA Received12/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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