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

Catalog Number IAP-0500

Device Problems Gas/Air Leak (2946); Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) helium tank gauge fluctuated back and forth.With random amounts of psi 10- 100+, also 1 unable to refill alarm.The pumping resumed after alarm, fluctuating psi did not affect the therapy.Patient successfully weaned from iab as planned.The patient has remained stable off the pump.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The report complaint of helium reading fluctuated and unable to refill alarm is confirmed based on the customer picture/video provided, however, the returned helium regulator assembly passed visual and functional test specifications during the complaint investigation.The root cause of the complaint is undetermined.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon pump (iabp) helium tank gauge fluctuated back and forth.With random amounts of psi 10- 100+, also 1 unable to refill alarm.The pumping resumed after alarm, fluctuating psi did not affect the therapy.Patient successfully weaned from iab as planned.The patient has remained stable off the pump.There was no report of delay in therapy.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: 9194287
• MDR Text Key: 183314087
• Report Number: 3010532612-2019-00373
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• 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: 10/23/2019
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1