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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 07/18/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after 40 minutes of insertion of the intra-aortic balloon(iab) there was obvious blood in the gas tubing.Therefore, the iab was removed and another iab was successfully inserted.There was no patient death and patient's current condition is reported as fine.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.A bladder leak was noted on the iab, which can cause blood to enter the helium pathway.The root cause of the bladder leak is unconfirmed, but the probable cause is contact with calcified plaque.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.No further action required at this time.This will be monitored for any developing trends.Other remarks: additional information received via a user facility report patient was in ccl (cardiac cath lab) holding room post-intraaortic balloon pump replacement, while waiting for icu rn to call ccl rn for report.Blood noted in iabp arterial pressure line; iabp alarmed; blood quickly advanced helium tubing.There was concern for balloon rupture given blood in line.Patient became hypoxic and hypotensive.He was emergently brought into the cath lab where balloon was removed and a new 40cc iabp was placed under fluoroscopy.Blood was noted inside first balloon with no evidence of tear or rupture seen.Patient received 1 unit of blood, as well as epinephrine and dopamine.Preexisting patient conditions: decompensated systolic heart failure, severe triple vessel disease, ischemic cardiomyopathy with reduced left ventricular (lv) function.
 
Event Description
It was reported that after 40 minutes of insertion of the intra-aortic balloon(iab) there was obvious blood in the gas tubing.Therefore, the iab was removed and another iab was successfully inserted.There was no patient death and patient's current condition is reported as fine.Per additional information received from the cath lab director, it was reported that the patient was very dependent on the balloon pump.The patient verbalized not feel well and told the nurse "i'm going out".The patient's blood pressure dropped down to the 50's/60's systolic.Therefore, an impella was inserted.It was reported the patient was not a surgical candidate.
 
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Brand Name
FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7781012
MDR Text Key117296785
Report Number3010532612-2018-00256
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902007247
UDI-Public00801902007247
Combination Product (y/n)N
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F18B0012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Date Manufacturer Received09/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EPINEPPHRINEDOPAMINE
Patient Age60 YR
Patient Weight63
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