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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC INTRA- AORTIC BALLOOON PRODUCTS

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-S840C
Device Problem Insufficient Information (3190)
Patient Problems Atherosclerosis (1728); Cardiogenic Shock (2262)
Event Date 05/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Sample not expected to be returned.
 
Event Description
It was reported that while in the cath lab the iab was inserted via the patient's femoral artery. During use there was an occurrence and as a result the iab was removed and replaced. There was no reported patient death, injury or complications. There was no delay or interruption in iabp therapy.
 
Manufacturer Narrative
(b)(4) additional information received on 07/18/2016. The occurrence was blood in the helium pathway, and as a result the iab was removed and replaced. The second iab was inserted via the same insertion site, right femoral artery via a sheath. There was a 10 minute delay / interruption in iabp therapy. The procedure was successful. No product was returned for evaluation. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the reported complaint of blood in helium pathway is not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined. If the sample is returned at a later date, a full investigation will be completed.
 
Event Description
It was reported that while in the cath lab the iab was inserted via the patient's femoral artery. During use there was an occurrence and as a result the iab was removed and replaced. There was no reported patient death, injury or complications. There was no delay or interruption in iabp therapy.
 
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Brand NameREDIGUARD IAB: 8FR 40CC
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 Key5741936
MDR Text Key47957670
Report Number1219856-2016-00148
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
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 05/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Catalogue NumberIAB-S840C
Device Lot Number18F15B0013
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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