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

Catalog Number IAP-0500

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after insertion of the intra-aortic balloon (iab), the staff were unable to get the pump to initiate pumping, each time they attempt to pump, they have the purge failure alarms.As a result, the iab was removed because there was no other pump available to support the patient.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "purge failure alarm" is confirmed.The inlet fitting and 1 psi release valve were noted damaged, which could result in the reported alarm.The root cause of how the pcs assembly got damaged is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that after insertion of the intra-aortic balloon (iab), the staff were unable to get the pump to initiate pumping, each time they attempt to pump, they have the purge failure alarms.As a result, the iab was removed because there was no other pump available to support the patient.There was no report of patient complications, serious injury or death.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8549206
• MDR Text Key: 143053976
• Report Number: 3010532612-2019-00111
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902051714
• UDI-Public: 00801902051714
• Combination Product (y/n): N
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1