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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06830-U
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that "balloon catheter cannot detect arterial pressure.Doctor had to remove the alleged balloon and replaced with new one".Additional information states that the catheter was not replaced.No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4).The reported complaint that the "balloon catheter cannot detect arterial pressure" was not able to be confirmed as 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 was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that "balloon catheter cannot detect arterial pressure.Doctor had to remove the alleged balloon and replaced with new one".Additional information states that the catheter was not replaced.No patient harm or injury.The patient status is reported as "fine".
 
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Brand Name
ULTRAFLEX IAB: 7.5FR 30CC
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
kevin don bosco
3015 carrington mill blvd
morrisville 27560
MDR Report Key18427808
MDR Text Key331873738
Report Number3010532612-2024-00008
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902003751
UDI-Public00801902003751
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/13/2023
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 Catalogue NumberIAB-06830-U
Device Lot Number18F23J0011
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/13/2023
Initial Date FDA Received01/02/2024
Supplement Dates Manufacturer Received02/01/2024
Supplement Dates FDA Received02/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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