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

Catalog Number	IAP-0500
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported as "continued ecg interference".The report states that "the iabp was dropping beats and they had to go to operator to resolve this, but is now unsure of the timing.Patient is in afib with hr 55-90.Map cal completed to ensure accuracy of hemodynamics.Manual timing in operator attempted and resulted in repeated timing errors, including early inflations/late deflations with arrythmia.Pump placed in autopilot, which continued to have dropped beats d/t variable qrs heights.We discussed this and its impact on timing/therapy.Lead set analysis is poor and we discussed what this means.Ecg stickers replaced and moved on patient.Trunk cable exchanged.The account did not have another set of iabp ecg leads to attempt.There was no notable change to the lead signal or analysis.Signals moved to second iabp with improvement in lead set analysis and waveform.Iabp dropping beats with less frequency and lead set analysis improved".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Reported as "continued ecg interference".The report states that "the iabp was dropping beats and they had to go to operator to resolve this, but is now unsure of the timing.Patient is in afib with hr 55-90.Map cal completed to ensure accuracy of hemodynamics.Manual timing in operator attempted and resulted in repeated timing errors, including early inflations/late deflations with arrythmia.Pump placed in autopilot, which continued to have dropped beats d/t variable qrs heights.We discussed this and its impact on timing/therapy.Lead set analysis is poor and we discussed what this means.Ecg stickers replaced and moved on patient.Trunk cable exchanged.The account did not have another set of iabp ecg leads to attempt.There was no notable change to the lead signal or analysis.Signals moved to second iabp with improvement in lead set analysis and waveform.Iabp dropping beats with less frequency and lead set analysis improved".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "ecg interference" was confirmed based on the customer supplied pictures.The attached pictures show the pump experienced triggering difficulty (missing beats).No part was returned for investigation.No service updates have been received as per the field service management.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action was required at this time.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: AUTOCAT2 WAVE
• Common Device Name: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17835936
• Report Number: 3010532612-2023-00558
• Device Sequence Number: 7456560
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male