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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000260
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
It was reported that at the time of insertion, it was noted that there was a kink at the proximal end of the intra-aortic balloon (iab) and so the iab could not be used.As a result, a new iab was used.There was no report of patient complications, serious injury or death.
 
Event Description
It was reported that at the time of insertion, it was noted that there was a kink at the proximal end of the intra-aortic balloon (iab) and so the iab could not be used.As a result, a new iab was used.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of iab kinked is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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 revived risk.This will be monitored for any developing trends.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported compliant of iab kinked is confirmed.A kink to the central lumen was noted during the functional testing of the returned iabc, and resistance was noted at the location of the kink upon loading a guidewire into the iabc central lumen.The root cause of the kinks is undetermined, but a potential cause is customer handling.Additionally, the original packaging tray was noted with damage to the "arrow" packaging sticker which retains the iabc bladder in the packaging tray.This damage indicates the iabc was not prepped correctly per the ifu and can result in damage to the iabc.An in-service has been requested to reiterate the instructions for use (ifu), including the appropriate method for iabc prep/removal from its packaging.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 revived risk.This will be monitored for any developing trends.
 
Event Description
It was reported that at the time of insertion, it was noted that there was a kink at the proximal end of the intra-aortic balloon (iab) and so the iab could not be used.As a result, a new iab was used.There was no report of patient complications, serious injury or death.
 
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Brand Name
ULTRAFLEX IAB: 7.5FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10635322
MDR Text Key210014549
Report Number3010532612-2020-00292
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902026804
UDI-Public00801902026804
Combination Product (y/n)N
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Model NumberIPN000260
Device Catalogue NumberIAB-06840-U
Device Lot Number18F19H0032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Date Manufacturer Received02/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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