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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC INTRA- AORTIC BALLOOON PRODUCTS

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-S730C
Device Problem Inflation Problem (1310)
Patient Problems Myocardial Infarction (1969); Cardiogenic Shock (2262)
Event Date 04/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Sample is not returning to the manufacturer.
 
Event Description
It was reported that the event involved a patient (b)(6) in height. While in the cath lab the md inserted the intra- aortic balloon (iab) via the patient's right femoral artery. Under fluoroscopy the balloon was not completely expanding, only the proximal and distal end of the iab is expanding completely. As a result augmentation during systole is not optimal (low diastolic augmentation). The iab was not removed. There was no reported patient death, injury or complications. Medical/ surgical intervention was not required. There was no delay or interruption in iabp therapy. The outcome of the patient was okay and stable. The iabp used was arrow autocat2 wave.
 
Manufacturer Narrative
(b)(4). No product was returned for evaluation. The customer photos were reviewed; inflation difficulty cannot be confirmed from the photos. A cd-rom was received but the contents were unable to be opened or viewed. A device history record (dhr) review was unable to be completed. No lot number was reported. The lot numbers at this account are unable to be retrieved at this time. When the dhr is completed, the complaint will be updated accordingly. The reported complaint of would not inflate completely is not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined.
 
Event Description
It was reported that the event involved a patient (b)(6) in height. While in the cath lab the md inserted the intra- aortic balloon (iab) via the patient's right femoral artery. Under fluoroscopy the balloon was not completely expanding, only the proximal and distal end of the iab is expanding completely. As a result augmentation during systole is not optimal (low diastolic augmentation). The iab was not removed. There was no reported patient death, injury or complications. Medical/ surgical intervention was not required. There was no delay or interruption in iabp therapy. The outcome of the patient was okay and stable. The iabp used was arrow autocat2 wave.
 
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Brand NameREDIGUARD IAB: 7FR 30CC
Type of DeviceINTRA- AORTIC BALLOOON PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key6074765
MDR Text Key59027674
Report Number1219856-2016-00257
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAB-S730C
Device Lot NumberN/A
Other Device ID Number00801902002686
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/02/2016 Patient Sequence Number: 1
Treatment
INTUBATION / VENTILATION
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