MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT 2; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN000302
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "on the evening of (b)(6), the equipment was put into use.On the morning of (b)(6), it was found that there was no gas in the helium cylinder.The hospital urgently borrowed a bottle of helium from the first hospital of nantong city for replacement, and the agent nanjing quankang trading co., ltd.Also sent someone to drive a bottle from suzhou for standby.The device was stopped for about 1 hour.At about 5:00 p.M.On (b)(6), the doctor found that the pressure of the helium gas replaced in the morning had dropped to less than 100psi.He checked the gasket of the gas cylinder and the gas transfer valve of the helium cylinder, and no problem was found.After replacing the whole bottle of helium, he found that the gas dropped rapidly, and it was suspected that the gas pressure reducing valve was faulty.At 1:00 p.M.On (b)(6) 2022 the engineers of nanjing quankang trading co., ltd.A rrived at the hospital and replaced the pressure reducing valve on the hospital machine with the pressure reducing valve on the company's sample machine.After testing for 1 hour, the gas pressure dropped by 2psi, which was within the normal range.When the equipment was working until noon on the (b)(6), the gas pressure dropped by 5 psi, which was within the normal range.At 17:30 on (b)(6) 2022, the machine was removed and the patient was in good condition".Additional information received stated that no medical intervention was necessary when the pressure dropped and when the device stopped for about one hour.Patient condition reported as "fine".
Event or Problem Description
It was reported that "on the evening of (b)(6) , the equipment was put into use.On the morning of august 13, it was found that there was no gas in the helium cylinder.The hospital urgently borrowed a bottle of helium from (b)(6) hospital for replacement, and the agent (b)(4).Also sent someone to drive a bottle from (b)(6) for standby.The device was stopped for about 1 hour.At about 5:00 p.M.On august 13, the doctor found that the pressure of the helium gas replaced in the morning had dropped to less than 100psi.He checked the gasket of the gas cylinder and the gas transfer valve of the helium cylinder, and no problem was found.After replacing the whole bottle of helium, he found that the gas dropped rapidly, and it was suspected that the gas pressure reducing valve was faulty.At 1:00 p.M.On august 14, the engineers of nanjing quankang trading co., ltd.A rrived at the hospital and replaced the pressure reducing valve on the hospital machine with the pressure reducing valve on the company's sample machine.After testing for 1 hour, the gas pressure dropped by 2psi, which was within the normal range.When the equipment was working until noon on the 14th, the gas pressure dropped by 5 psi, which was within the normal range.At 17:30 on august 15, the machine was removed and the patient was in good condition".Additional information received stated that no medical intervention was necessary when the pressure dropped and when the device stopped for about one hour.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: AUTOCAT 2
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15442701
• Report Number: 3010532612-2022-00358
• Device Sequence Number: 17561004
• Product Code: DSP
• UDI-Device Identifier: 30801902051722
• UDI-Public: 30801902051722
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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
• Device Model Number: IPN000302
• Device Catalogue Number: IAP-0400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown