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

Model Number	IPN000324
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
There was no patient involvement.It was reported that "helium leakage" occurred during service.The intra-aortic balloon pump (iabp) has not been used since april.As a result, the pump assembly was replaced, and the iabp was returned to service.
Event or Problem Description
There was no patient involvement.It was reported that "helium leakage" occurred during service.The intra-aortic balloon pump (iabp) has not been used since april.As a result, the pump assembly was replaced, and the iabp was returned to service.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of "helium leakage" is confirmed.The pump alarmed possible helium loss (2) during the complaint investigation.A leak was detected from the bellows assembly.The root cause of this complaint is undetermined.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 revised risk.This will be monitored for any developing trends.

• Brand Name: AUTOCAT2 WAVE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12338484
• Report Number: 3010532612-2021-00250
• Device Sequence Number: 3602661
• Product Code: DSP
• UDI-Device Identifier: 30801902092190
• UDI-Public: 30801902092190
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: IPN000324
• Device Catalogue Number: IAP-0500I
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1