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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2024
Event Type  Injury  
Event Description
It was reported that "when the doctor removed the balloon counterpulsation catheter implanted via the femoral artery, he was unable to remove it.After consultation with vascular surgery, the local femoral artery was incised and removed, and the examination found that the balloon was leaking and there was thrombosis." patient's current condition is reported as "fine".
 
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that "when the doctor removed the balloon counterpulsation catheter implanted via the femoral artery, he was unable to remove it.After consultation with vascular surgery, the local femoral artery was incised and removed, and the examination found that the balloon was leaking and there was thrombosis." patient's current condition is reported as "fine".
 
Manufacturer Narrative
(b)(4).The reported complaint for iab "balloon was leaking" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
 
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Brand Name
ARROW ULTRAFLEX IAB: 7.5FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18820180
MDR Text Key336734886
Report Number3010532612-2024-00130
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberIAB-06840-U
Device Lot Number18F23L0029
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
Patient SexMale
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