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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000262
Device Problem Difficult to Insert (1316)
Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
Event Date 10/21/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the front end of the intra-aortic balloon (iab) was too large.As a result, a new catheter was used, and another attempt was performed successfully.There was no report of patient death.Additional information received.It was reported that the second iab used the md changed site insertion from the right femoral artery to the left femoral artery.There was no report of patient complications.
 
Manufacturer Narrative
Qn#: (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab would not inflate completely is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned later, a full investigation of the sample will be completed.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 revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
 
Event Description
It was reported that the front end of the intra-aortic balloon (iab) was too large.As a result, a new catheter was used, and another attempt was performed successfully.There was no report of patient death.Additional information received.It was reported that the second iab used the md changed site insertion from the right femoral artery to the left femoral artery.There was no report of patient complications.
 
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Brand Name
REDIGUARD IAB: 7FR 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9706645
MDR Text Key179270707
Report Number3010532612-2020-00051
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902002686
UDI-Public00801902002686
Combination Product (y/n)N
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Model NumberIPN000262
Device Catalogue NumberIAB-S730C
Device Lot Number18F19H0012
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/22/2020
Initial Date FDA Received02/13/2020
Supplement Dates Manufacturer Received01/22/2020
Supplement Dates FDA Received03/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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