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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. INTRA-AORTIC BALLOON CATHETER KIT
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ARROW INTERNATIONAL INC. INTRA-AORTIC BALLOON CATHETER KIT Back to Search Results
Catalog Number CARDIAC UNKNOWN
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Customer reported that the balloon burst from a previous patient.The presence of blood on the balloon connector and internal parts of the pump was found.Patient information is unknown at this time.There was no report of complication, serious injury, or death to the patient.
 
Manufacturer Narrative
Qn# (b)(4).The product was not returned for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.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 risk.This will be monitored for any developing trends.
 
Event Description
Customer reported that the balloon burst from a previous patient.The presence of blood on the balloon connector and internal parts of the pump was found.Patient information is unknown at this time.There was no report of complication, serious injury, or death to the patient.
 
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Brand Name
INTRA-AORTIC BALLOON CATHETER KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12338908
MDR Text Key268541777
Report Number3010532612-2021-00251
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCARDIAC UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received09/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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