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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
Catalog Number IAB-06840-U
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that prior to use on patient it was noted when the intra-aortic balloon (iab) kit was opened that the outer tip of the sheath had damaged burrs, which affected the normal puncture.As a result, the iab was replaced.Upon, returned of the iab, it was noted during investigation that based on the returned state of the device, there were evidence that the user attempted insertion despite the damaged state which could have led to a risk of vascular damage and excess bleeding.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of sheath damaged is confirmed.There was combined damaged on the returned dilators and sheath assembly.The damage was found at the tip of the parts upon return.The damage noted to the tip is a potential result of customer handling and/or patient anatomy; however, the event details state the damage was noted as "burrs" to the tip and the cause of the complaint could not be determined.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.
 
Event Description
It was reported that prior to use on patient it was noted when the intra-aortic balloon (iab) kit was opened that the outer tip of the sheath had damaged burrs, which affected the normal puncture.As a result, the iab was replaced.Upon, returned of the iab, it was noted during investigation that based on the returned state of the device, there were evidence that the user attempted insertion despite the damaged state which could have led to a risk of vascular damage and excess bleeding.There was no report of patient complications, serious injury or death.
 
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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 Key11413436
MDR Text Key240369395
Report Number3010532612-2021-00052
Device Sequence Number1
Product Code DSP
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,distri
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2020
Device Catalogue NumberIAB-06840-U
Device Lot Number18F18F0020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Date Manufacturer Received04/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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