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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL LLC AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000320
Device Problem Output Problem (3005)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/13/2022
Event Type  Death  
Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
 
Event Description
The report states, "inserting intra-aortic balloon pump into patient with cardiogenic shock.Balloon catheter inserted without incident.Substitute balloon was used that had no cal key so unable to zero fos key.Able to zero arterial pressure.No ecg tracing was showing on the screen.Connections were double-checked, electrodes were changed but still no ecg tracing to allow pump to use for auto-pilot mode.Also, there was no arterial pressure tracing despite adequate connections, which could have been used for iabp to sense and pump.This was noted after balloon catheter was already in-situ, so it was urgent to get it working.Unable to change mode to cpr mode either.Manual balloon inflations were initiated to prevent clotting.Had to send for replacement pump from ccu.By that time, patient had arrested, and cpr was initiated.Patient was in cardiogenic shock upon arrival.Despite coronary interventions, patient ended up in cardiac arrest and died".Multiple attempts were made to the customer to clarify information surrounding the death of the patient and performance of the pump.The customer did not respond to any of the inquiries.If further information is received on this complaint, the complaint file will be updated.
 
Event Description
The report states, "inserting intra-aortic balloon pump into patient with cardiogenic shock.Balloon catheter inserted without incident.Substitute balloon was used that had no cal key so unable to zero fos key.Able to zero arterial pressure.No ecg tracing was showing on the screen.Connections were double-checked, electrodes were changed but still no ecg tracing to allow pump to use for auto-pilot mode.Also, there was no arterial pressure tracing despite adequate connections, which could have been used for iabp to sense and pump.This was noted after balloon catheter was already in-situ, so it was urgent to get it working.Unable to change mode to cpr mode either.Manual balloon inflations were initiated to prevent clotting.Had to send for replacement pump from ccu.By that time, patient had arrested, and cpr was initiated.Patient was in cardiogenic shock upon arrival.Despite coronary interventions, patient ended up in cardiac arrest and died".Multiple attempts were made to the customer to clarify information surrounding the death of the patient and performance of the pump.The customer did not respond to any of the inquiries.If further information is received on this complaint, the complaint file will be updated.
 
Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Additionally no recorder strip was returned for investigation.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
 
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Brand Name
AUTOCAT2 WAVE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
bryanna connelly
3015 carrington mill blvd
morrisville 27560
MDR Report Key16036352
MDR Text Key306020841
Report Number3010532612-2022-00557
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/29/2022
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 Model NumberIPN000320
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/29/2022
Initial Date FDA Received12/22/2022
Supplement Dates Manufacturer Received01/18/2023
Supplement Dates FDA Received01/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
N/A.; N/A.
Patient Outcome(s) Death;
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