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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 Leak (1250); Material Rupture (1546)
Patient Problems Air Embolism (1697); Paresis (1998); Weakness (2145)
Event Date 10/15/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the registered nurse that blood was noted in the gas line tubing. The rn stated that there was no issue with placement of the intra-aortic balloon (iab) catheter, but once the patient was transferred, the patient experienced "left sided weakness" and blood was noted in the tubing. The intra-aortic balloon pump (iabp) had a helium loss alarm. The left sided weakness was resolved after removal of the iab. As a result, the catheter was removed without incident, and no other catheter was reinserted. There was a potential helium embolism questioned by the md. There was a report of delay in therapy and patient complication. There was no report of patient death. The patient was being monitored and stable.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of iab blood in the helium pathway is confirmed. A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the iab which allowed blood to enter the helium pathway. No other leaks were detected during functional testing. The root cause of the broken fiber 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 risks. This will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported by the registered nurse that blood was noted in the gas line tubing. The rn stated that there was no issue with placement of the intra-aortic balloon (iab) catheter, but once the patient was transferred, the patient experienced "left sided weakness" and blood was noted in the tubing. The intra-aortic balloon pump (iabp) had a helium loss alarm. The left sided weakness was resolved after removal of the iab. As a result, the catheter was removed without incident, and no other catheter was reinserted. There was a potential helium embolism questioned by the md. There was a report of delay in therapy and patient complication. There was no report of patient death. The patient was being monitored and stable.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8052753
MDR Text Key126589489
Report Number3010532612-2018-00333
Device Sequence Number1
Product Code DSP
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 10/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2020
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F18B0026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/08/2018 Patient Sequence Number: 1
Treatment
IV VASOPRESSORS; IV VASOPRESSORS; IV VASOPRESSORS
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