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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
Model Number IPN000260
Device Problems Fluid/Blood Leak (1250); Material Rupture (1546); Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/25/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when the intra-aortic balloon (iab) was in use, the staff noted blood in the driveline and there had been a possible helium loss alarm.As a result, the iab was swapped out.There was no report of patient complications, serious injury or death.
 
Event Description
It was reported that when the intra-aortic balloon (iab) was in use, the staff noted blood in the driveline and there had been a possible helium loss alarm.As a result, the iab was swapped out.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint that "blood was noted in the driveline" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.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.
 
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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 Key10270175
MDR Text Key198733761
Report Number3010532612-2020-00181
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,foreig
Type of Report Initial,Followup
Report Date 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Model NumberIPN000260
Device Catalogue NumberIAB-06840-U
Device Lot Number18F20C0054
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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