MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE ITALIAN; 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	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
There was no patient involvement.It was reported that helium leakage alarm occurred right after pumping started during corrective action.It was noted the machine was unable to pump, it systematically went to alarm.As a result, the interface block and pcs assembly were replaced, and the machine was returned to service.
Event or Problem Description
There was no patient involvement.It was reported that helium leakage alarm occurred right after pumping started during corrective action.It was noted the machine was unable to pump, it systematically went to alarm.As a result, the interface block and pcs assembly were replaced, and the machine was returned to service.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of helium loss alarm is confirmed.A leak was detected from the vent port of the pcs assembly and caused the pump to trigger "possible helium loss 2".The root cause of vent valve leak 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.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 ITALIAN
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12480290
• Report Number: 3010532612-2021-00253
• Device Sequence Number: 19919905
• 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): 08/18/2021

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: 09/07/2021
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1