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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 Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a hot line call from a fellow cardiologist that the (rn) registered nurse had turned the patient in the bed and now there is blood (small amount) in the gas line tubing. The fellow notified the attending and was told it was ok to leave and the fellow was questioning this. The (css) clinical support specialist explained that the fellow is correct, pumping should stop and the iab must be immediately removed. The css and fellow discussed clotting and catheter entrapment. The fellow is going to call the css back post removal to update the css. At 2148 est- the fellow called the css back the iab was immediately removed without incident. They have decided not to reinsert at this time. There are no noted complications and the iab was kept as requested for return. (the fellow is unable to provide the css with serial numbers) the fellow stated that there was no blood noted back to the pump. The css told the fellow they should have the pump checked by biomed to be sure and the fellow understood. On (b)(6) 2016- 0945 the css spoke to the rn who is the nurse for the patient on this day. The rn stated the patient is critical but maintaining pressures with minimal dose dopamine so they have opted still to not reinsert. There are no noted complications at this time.
 
Manufacturer Narrative
(b)(4). No product was returned for evaluation. The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers at this account with no relevant findings. All devices 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 via a hot line call from a fellow cardiologist that the (rn) registered nurse had turned the patient in the bed and now there is blood (small amount) in the gas line tubing. The fellow notified the attending and was told it was ok to leave and the fellow was questioning this. The (css) clinical support specialist explained that the fellow is correct, pumping should stop and the iab must be immediately removed. The css and fellow discussed clotting and catheter entrapment. The fellow is going to call the css back post removal to update the css. At 2148 est- the fellow called the css back the iab was immediately removed without incident. They have decided not to reinsert at this time. There are no noted complications and the iab was kept as requested for return. (the fellow is unable to provide the css with serial numbers) the fellow stated that there was no blood noted back to the pump. The css told the fellow they should have the pump checked by biomed to be sure and the fellow understood. On (b)(6) 2016- 0945 the css spoke to the rn who is the nurse for the patient on this day. The rn stated the patient is critical but maintaining pressures with minimal dose dopamine so they have opted still to not reinsert. There are no noted complications at this time.
 
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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 Key6057784
MDR Text Key58417707
Report Number1219856-2016-00232
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 09/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCARDIAC UNKNOWN
Device Lot NumberN/A
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 Received11/22/2016
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

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