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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-05830-LWS
Device Problems Material Rupture (1546); Gas/Air Leak (2946)
Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
Event Date 10/20/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Other remarks: for complaints involving the same patient and event see: mdr #3010532612-2019-00397 and (b)(4), mdr #3010532612-2019-00398 and (b)(4), mdr #3010532612-2019-00396 and (b)(4).
 
Event Description
It was reported by the rn that the intra-aortic balloon pump (iabp) has constant helium loss alarms.The rn called the hotline to discuss the helium loss alarms.The intra-aortic balloon (iab) was inserted in the cath lab and removed immediately due to "so much calcification that the iab was shredded".There was no blood noted in the tubing, helium loss alarms less than 2 minutes apart.A leak test was performed and the iab failed the test.The iabp was exchanged as well as the helium tanks.As a result, the surgeon opted to not reinsert as the patient is stable and "doing well".It was reported that for the fourth iab insertion the md used the opposite groin.The patient was reported to be stable off the iabp.There was no report of patient complications or consequence.
 
Event Description
It was reported by the rn that the intra-aortic balloon pump (iabp) has constant helium loss alarms.The rn called the hotline to discuss the helium loss alarms.The intra-aortic balloon (iab) was inserted in the cath lab and removed immediately due to "so much calcification that the iab was shredded".There was no blood noted in the tubing, helium loss alarms less than 2 minutes apart.A leak test was performed and the iab failed the test.The iabp was exchanged as well as the helium tanks.As a result, the surgeon opted to not reinsert as the patient is stable and "doing well".It was reported that for the fourth iab insertion the md used the opposite groin.The patient was reported to be stable off the iabp.There was no report of patient complications or consequence.
 
Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab balloon damaged is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed 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.Other remarks: for complaints involving the same patient and event see: mdr #3010532612-2019-00397 and tc #1900072910, mdr #3010532612-2019-00398 and tc #1900072911, mdr #3010532612-2019-00396 and tc #1900072891.
 
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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 Key9309944
MDR Text Key166933371
Report Number3010532612-2019-00399
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 10/20/2019
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 Catalogue NumberIAB-05830-LWS
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/20/2019
Initial Date FDA Received11/12/2019
Supplement Dates Manufacturer Received12/17/2019
Supplement Dates FDA Received12/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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