MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-S840C
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the catheter was inserted and they noticed blood return in the helium connection.They stop the process and used a new catheter because they noticed the tip was broken." no patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint for iab "blood return in the helium connection" was confirmed based on the customer photos provided with the complaint report.The first photo showed the intra-aortic balloon catheter (iabc) carton label, the second photo showed a label on the iabc carton, the third photo showed what appeared to be the sheath tip and blood noted coming from the sheath tip.There's an iabc noted in the background of the photo, which showed blood within the iabc helium pathway/short driveline tubing, which was consistent with the reported complaint.The customer video was reviewed; the video showed a brief view of what appeared to the sheath tip and blood noted coming from the sheath tip.No obvious abnormality or damage was noted to the sheath tip in the video and previous photo.There was an iabc noted in the background of the video, which showed blood within the iabc helium pathway/short driveline tubing.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specific ation upon release; however, the specifications were not met during the complaint investigation due to the blood in helium pathway.The root cause of the complaint was undetermined.No further action was required at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.
Event or Problem Description
It was reported that "the catheter was inserted and they noticed blood return in the helium connection.They stop the process and used a new catheter because they noticed the tip was broken." no patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17434471
• Report Number: 3010532612-2023-00455
• Device Sequence Number: 8898609
• Product Code: DSP
• UDI-Device Identifier: 10801902161977
• UDI-Public: 10801902161977
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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 Expiration Date: 10/31/2024
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22K0060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown