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

Catalog Number	IAP-0500
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the bpw looked like a severe kink and was consistently below the baseline.There were no alarms.The ap waveform did not show any aug, only a "normal" ap waveform.Also noted when the iab was on standby, the baseline of the bpw did not go to the home position and was "wavy".We initially decreased the iab volume to 28cc without much change in the waveform.I also had her reposition the patient to hyper-extend the hip without resolution.I asked the nurse to get a second pump console and connect to see if the same waveforms were present.They were.The patient's pressures were very low, and he was on [levophed] and [epinephrin].I suggested she get a stat cxr and call the provider.I gave her my direct number to follow-up.The surgeon came in and suspected an aortic dissection and took the patient to the or for removal of the iab and repair of the aorta.Pt had dissection from the aortic root to beyond the renal arteries as well as a "blown" av.They also performed an exploratory lap on him and removed his gallbladder.The plan is to go on crrt post op.No additional information was able to be obtained".
Event or Problem Description
It was reported that "the bpw looked like a severe kink and was consistently below the baseline.There were no alarms.The ap waveform did not show any aug, only a "normal" ap waveform.Also noted when the iab was on standby, the baseline of the bpw did not go to the home position and was "wavy".We initially decreased the iab volume to 28cc without much change in the waveform.I also had her reposition the patient to hyper-extend the hip without resolution.I asked the nurse to get a second pump console and connect to see if the same waveforms were present.They were.The patient's pressures were very low, and he was on [levophed] and [epinephrin].I suggested she get a stat cxr and call the provider.I gave her my direct number to follow-up.The surgeon came in and suspected an aortic dissection and took the patient to the or for removal of the iab and repair of the aorta.Pt had dissection from the aortic root to beyond the renal arteries as well as a "blown" av.They also performed an exploratory lap on him and removed his gallbladder.The plan is to go on crrt post op.No additional information was able to be obtained".
Additional Manufacturer Narrative
(b)(4).Udi number unavailable as complainant did not report a lot number.The reported complaint of ap/bpw waveform abnormal is confirmed based on photos provided by the customer.No part was returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to ap/bpw waveforms abnormality.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19374802
• Report Number: 3010532612-2024-00385
• Device Sequence Number: 18024566
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: 04/25/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/17/2024
• 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: Unknown