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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; INTRA- AORTIC BALLOON FIBER OPTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05830-LWS
Device Problems Inflation Problem (1310); Increase in Pressure (1491); Obstruction of Flow (2423)
Patient Problems Death (1802); Cardiogenic Shock (2262); Chest Tightness/Pressure (2463)
Event Date 01/23/2017
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that in an emergency case in coronarographic lab the counter-pulsation device gave off an alarm sound with the message indicating "balloon pressure too high".The balloon was exchanged and the device did not recognize the optical fiber, balloon is changed again and the problem is the same.The patient did not have the best chance possible.This is the second incident in few months, which has already been declared.Additional information received on 1/27/17: it was reported that an ambulance was called for a patient in critical condition.The medical staff started the process with a 30cc intra-aortic balloon (iab) balloon.The device worked for 10 minutes.Then the counter-pulsation device gave off an alarm sound with the message indicating "balloon pressure too high".The connectors were checked and they were properly functional.The device was still working.The balloon was changed with a 40cc iab balloon.The device did not recognize the optical fiber.They changed the balloon with another 40cc balloon, the same problem occurred.The patient was in a critical condition and the use of the balloon was a last chance attempt.
 
Manufacturer Narrative
(b)(4).Teleflex received the reported device for analysis.The high pressure alarm was unable to be duplicated during functional testing.The iab passed functional testing therefore, the root cause of the reported complaint is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.
 
Event Description
It was reported that in an emergency case in coronarographic lab the counter-pulsation device gave off an alarm sound with the message indicating "balloon pressure too high".The balloon was exchanged and the device did not recognize the optical fiber, balloon is changed again and the problem is the same.The patient did not have the best chance possible.This is the second incident in few months, which has already been declared.Additional information received on 1/27/2017: it was reported that an ambulance was called for a patient in critical condition.The medical staff started the process with a 30 cc intra-aortic balloon (iab) balloon.The device worked for 10 minutes.Then the counter-pulsation device gave off an alarm sound with the message indicating "balloon pressure too high".The connectors were checked and they were properly functional.The device was still working.The balloon was changed with a 40 cc iab balloon.The device did not recognize the optical fiber.They changed the balloon with another 40 cc balloon, the same problem occurred.The patient was in a critical condition and the use of the balloon was a last chance attempt.
 
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Brand Name
FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Type of Device
INTRA- 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
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6296959
MDR Text Key66383893
Report Number1219856-2017-00025
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2018
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F16E0026
Other Device ID Number00801902034724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/25/2017
Initial Date FDA Received02/02/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age73 YR
Patient Weight70
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