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

Model Number IPN000320

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

It was reported by a field service representative (fsr) that a purge failure occurred during use on a patient.As a result, the pump was swapped out.There was no report of patient complications, serious injury, or death.Fsr was unable to reproduce symptom.

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

(b)(4).The reported complaint of "purge failure alarm" is not able to be confirmed.No part or recorder strip was returned to manufacturer for investigation.The field service agent serviced the pump and could not reproduce the issue.Based on a review of the device history record (dhr), the product met specification upon release.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.

Event Description

It was reported by a field service representative (fsr) that a purge failure occurred during use on a patient.As a result, the pump was swapped out.There was no report of patient complications, serious injury, or death.Fsr was unable to reproduce symptom.

• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15014819
• MDR Text Key: 304715442
• Report Number: 3010532612-2022-00254
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000320
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• 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 Number: 1
• Treatment: NONE REPORTED; NONE REPORTED