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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
Catalog Number IAB-06840-U
Device Problems Break (1069); Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem Death (1802)
Event Date 08/28/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was noted to have a leak when inflated after insertion.The patient's blood vessels are tortuous.As a result, the iab was removed, and a new iab was used.There was a report of patient death.Doctor (b)(6) made the judgement that the device did not contribute to patient's death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iab leak suspected is confirmed.A puncture to the bladder, consistent with contact from a sharp object, was found on the bladder membrane which allowed blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause of the bladder leak is undetermined, but a potential cause of how the catheter came into contact with a sharp object is due to customer handling.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 the intra-aortic balloon (iab) was noted to have a leak when inflated after insertion.The patient's blood vessels are tortuous.As a result, the iab was removed, and a new iab was used.There was a report of patient death.Doctor (b)(6) made the judgement that the device did not contribute to patient's 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 Key9187245
MDR Text Key182786668
Report Number3010532612-2019-00362
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
Report Date 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2021
Device Catalogue NumberIAB-06840-U
Device Lot Number18F19B0014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2019
Initial Date Manufacturer Received 09/18/2019
Initial Date FDA Received10/14/2019
Supplement Dates Manufacturer Received11/07/2019
Supplement Dates FDA Received11/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age53 YR
Patient Weight60
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