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

Model Number	IPN000325
Medical Device Problem Codes	Pumping Stopped (1503); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that helium loss alarms frequently occurred after the intra-aortic balloon pump (iabp) initiated pumping, 15 minutes later pumping stopped frequently.As a result, the iabp was replaced with a backup iabp and the procedure continued successfully.There was no report of patient complications, serious injury or death.
Event or Problem Description
It was reported that helium loss alarms frequently occurred after the intra-aortic balloon pump (iabp) initiated pumping, 15 minutes later pumping stopped frequently.As a result, the iabp was replaced with a backup iabp and the procedure continued successfully.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
Qn# (b)(4).No iabp part or recorder strip has been returned to teleflex chelmsford for investigation.The reported complaint of iabp helium loss alarm is not able to be confirmed.The root cause of the complaint is undetermined.A potential cause is catheter related.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10842848
• Report Number: 3010532612-2020-00337
• Device Sequence Number: 19573324
• Product Code: DSP
• UDI-Device Identifier: 30801902043420
• UDI-Public: 30801902043420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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 Model Number: IPN000325
• Device Catalogue Number: IAP-0500J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1