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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC

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ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05840-U
Device Problem Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported that the event involved a patient; described as "unfit" health-wise. On (b)(6), at 1:00 pm an intra-aortic balloon (iab) was inserted via a sheath for a procedure. At 5:00 pm the cath lab manager said the pump alarmed, and they tried to troubleshoot by turning on and off again. However, the gas (helium) alarm was still appearing and the medical doctor (md) also claimed to "smell the helium. " the procedure was stopped right away. A second intra-aortic balloon (iab) was inserted and the procedure was continued. There was no reported patient injury and there was no delay or interruption in therapy reported. The patient was in stable condition after the intra-aortic balloon (iab) was removed. The patient passed away two days later. Per the medical doctor (md) the device did not cause or contribute to the patient death.
 
Manufacturer Narrative
(b)(4). Evaluation: a full evaluation could not be performed since the affected device was not returned for analysis. 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 helium loss alarms was not able to be confirmed. The product was not returned for evaluation therefore, the root cause of the complaint is undetermined.
 
Event Description
It has been reported that the event involved a patient; described as "unfit" health-wise. On (b)(6) at 1:00pm an intra-aortic balloon (iab) was inserted via a sheath for a procedure. At 5:00pm the cath lab manager said the pump alarmed, and they tried to troubleshoot by turning on and off again. However, the gas (helium) alarm was still appearing and the medical doctor (md) also claimed to "smell the helium. " the procedure was stopped right away. A second intra-aortic balloon (iab) was inserted and the procedure was continued. There was no reported patient injury and there was no delay or interruption in therapy reported. The patient was in stable condition after the intra-aortic balloon (iab) was removed. The patient passed away two days later. Per the medical doctor (md) the device did not cause or contribute to the patient death.
 
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Brand NameULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- AORTIC BALLOON FIBER OPTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
3015 carrington mill blvd
morrisville 27560
MDR Report Key6200720
MDR Text Key63195163
Report Number1219856-2016-00294
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K000729
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 06/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAB-05840-U
Device Lot NumberN/A
Other Device ID Number00801902010759
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 Received01/11/2017
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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