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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL; INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number CARDIAC UNKNOWN
Device Problems Difficult to Flush (1251); Occlusion Within Device (1423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Sample not returning to manufacturer.
 
Event Description
It was reported via a hotline call from the registered nurse (rn) from the cicu they have a patient that had a non-fiberoptix intra-aortic balloon catheter (iab) in for 2-3 days.The central lumen has clotted.The rn had questions about how quickly the catheter should be removed and maintaining the central lumen.The clinical support specialist (css) explained that with any arterial line regardless of where it is, it should be removed as soon as possible.In the case of the iab, there are times that the patient may be too unstable to remove the balloon right away.In those cases, the central lumen should be capped and no manipulated to reduce the possibility of the clot moving forward into the aorta.The patient would have to be closely monitored for adverse symptoms.The css and rn discussed maintenance of the central lumen.The css asked if they had seen a lot of dampening with this central lumen.The rn said that it had a lot of whip.They were changing the transducer set-up and that's when it clotted off.The css explained on some patients, the central lumen of the catheter would have to be aspirated and flushed more frequently.The css and rn talked about how small and long the central lumen of the balloon catheter is.If there is more of a steep angle of insertion or tortuosity this can slow the constant flow from the transducer through the central lumen and dampen or clot the central lumen.The staff would need to troubleshoot and aspirate and flush the central lumen more frequently.The rn did say that they use heparinized saline in their iab flush solution.The rn said that the md was removing the catheter.The patient is stable and they were planning to remove the catheter anyway.There is no product for return.
 
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 central lumen occluded 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 via a hotline call from the registered nurse (rn) from the cicu they have a patient that had a non-fiberoptix intra-aortic balloon catheter (iab) in for 2-3 days.The central lumen has clotted.The rn had questions about how quickly the catheter should be removed and maintaining the central lumen.The clinical support specialist (css) explained that with any arterial line regardless of where it is, it should be removed as soon as possible.In the case of the iab, there are times that the patient may be too unstable to remove the balloon right away.In those cases, the central lumen should be capped and no manipulated to reduce the possibility of the clot moving forward into the aorta.The patient would have to be closely monitored for adverse symptoms.The css and rn discussed maintenance of the central lumen.The css asked if they had seen a lot of dampening with this central lumen.The rn said that it had a lot of whip.They were changing the transducer set-up and that's when it clotted off.The css explained on some patients, the central lumen of the catheter would have to be aspirated and flushed more frequently.The css and rn talked about how small and long the central lumen of the balloon catheter is.If there is more of a steep angle of insertion or tortuosity, this can slow the constant flow from the transducer through the central lumen and dampen or clot the central lumen.The staff would need to troubleshoot and aspirate and flush the central lumen more frequently.The rn did say that they use heparinized saline in their iab flush solution.The rn said that the md was removing the catheter.The patient is stable and they were planning to remove the catheter anyway.There is no product for return.
 
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Brand Name
CARDIAC UNKNOWN DUMMY MATERIAL
Type of Device
INTRA- 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 Key5973505
MDR Text Key55477681
Report Number1219856-2016-00216
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 Nurse
Type of Report Initial,Followup
Report Date 08/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCARDIAC UNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/28/2016
Initial Date FDA Received09/23/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/20/2016
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 Sequence Number1
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