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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 Human-Device Interface Problem (2949)
Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817)
Event Date 03/23/2016
Event Type  Death  
Manufacturer Narrative
(b)(4) the sample will not be returning for investigation.
 
Event Description
It was reported that the patient (b)(6). In height, weight estimated related to bedridden received an iab catheter due to angina pectoris on (b)(6) 2016 via the left femoral artery. The iab catheter was removed on (b)(6) 2016. Three days later, the patient appeared with angina pectoris again and ecg (electrocardiogram) changes showing ischemia of the anterior wall. An iab catheter was inserted through the left femoral artery and was sutured to prevent it from migrating inside the patient. The patient complained of severe pain on the left low extremity on (b)(6) 2016. The doctor found the following signs: low temperature of left low extremity, no pulse of left dorsal artery. The thrombosis was diagnosed. Heparin was given, but the ck (creatine kinase), mro and serum cr (creatinine blood test) increased continuously. The left extremity necrosis was diagnosed on (b)(6) 2016 and the iab catheter was removed on the same day. The patient expired due to mof (multi-system organ failure) the next day. The catheter appeared to function appropriately with no issues prior to the noted lower extremity circulation compromise.
 
Manufacturer Narrative
(b)(4). No product was returned for evaluation. 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. Conclusion: there was no reported device failure. No product was returned for evaluation. The root cause of the complaint is undetermined.
 
Event Description
It was reported that the patient (b)(6). In height, weight estimated related to bedridden received an iab catheter due to angina pectoris on (b)(6) 2016 via the left femoral artery. The iab catheter was removed on (b)(6) 2016. Three days later, the patient appeared with angina pectoris again and ecg (electrocardiogram) changes showing ischemia of the anterior wall. An iab catheter was inserted through the left femoral artery and was sutured to prevent it from migrating inside the patient. The patient complained of severe pain on the left low extremity on (b)(6) 2016. The doctor found the following signs: low temperature of left low extremity, no pulse of left dorsal artery. The thrombosis was diagnosed. Heparin was given, but the ck (creatine kinase), mro and serum cr (creatinine blood test) increased continuously. The left extremity necrosis was diagnosed on (b)(6) 2016 and the iab catheter was removed on the same day. The patient expired due to mof (multi-system organ failure) the next day. The catheter appeared to function appropriately with no issues prior to the noted lower extremity circulation compromise.
 
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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 Key5706896
MDR Text Key46822220
Report Number1219856-2016-00123
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
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 05/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2016
Device Catalogue NumberIAB-S840C
Device Lot Number18F14E0041
Other Device ID Number00801902002679
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 Received07/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/15/2014
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: 06/08/2016 Patient Sequence Number: 1
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