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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN MATERIAL INTRA- AORTIC BALLOOON PRODUCTS

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ARROW INTERNATIONAL INC. CARDIAC UNKNOWN MATERIAL INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number CARDIAC UNKNOWN
Device Problems Fluid Leak (1250); Difficult to Remove (1528)
Patient Problems Death (1802); Thrombus (2101)
Event Date 09/19/2016
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had an intra-aortic balloon (iab) inserted and was receiving iabp therapy. The pump s/n (b)(4) alarmed three times, and the iab was removed 30 minutes or later. The nurse practitioner removed the iab and noted that there were clots formed on several areas of the balloon. The patient was not on heparin. The patient has expired. Additional information received on 10/5/2016: the balloon ruptured and the alarmed sounded several times. The attending instructed the np (nurse practitioner) not to extract the balloon at first but then instructed the np, to remove the catheter. Upon removal, the catheter developed several clots making it difficult to remove. Finally the catheter was removed but the clot migrated down the patient's leg. As a result of the clot moving, an embolectomy had to be performed. The responds to the alarms may have been longer than the 30 min window for clot development.
 
Manufacturer Narrative
(b)(4) additional information received on 11-29-2016 from the field service report that blood entered the intra-aortic balloon pump. The product was not returned for evaluation. The specific lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers shipped to this account with no relevant findings. All devices passed all manufacturing specifications prior to release. Conclusion: the reported complaint of blood in the helium pathway is not able to be confirmed. The product was not returned for evaluation. The root cause of the complaint is undetermined.
 
Event Description
It was reported that the patient had an intra-aortic balloon (iab) inserted and was receiving iabp therapy. The pump s/n (b)(4) alarmed three times, and the iab was removed 30 minutes or later. The nurse practitioner removed the iab and noted that there were clots formed on several areas of the balloon. The patient was not on heparin. The patient has expired. Additional information received on 10/5/2016: the balloon ruptured and the alarmed sounded several times. The attending instructed the np (nurse practitioner) not to extract the balloon at first but then instructed the np, to remove the catheter. Upon removal, the catheter developed several clots making it difficult to remove. Finally the catheter was removed but the clot migrated down the patient's leg. As a result of the clot moving, an embolectomy had to be performed. The responds to the alarms may have been longer than the 30 min window for clot development.
 
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Brand NameCARDIAC UNKNOWN MATERIAL
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 Key6072837
MDR Text Key58971694
Report Number1219856-2016-00234
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2016
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? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCARDIAC UNKNOWN
Device Lot NumberN/A
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
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