MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN039779
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "patient suffered from acute myocardial infarction and was sent to the ccu for emergency treatment.After the operation, the iab catheter was inserted for assistance.Blood was found, after checking, it was found that the balloon was ruptured.As a result, the catheter was replaced at the same insertion site and worked as expected.There was no report of patient complications, serious injury or death.".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).No serial number was reported.The serial number on the returned sample is bz20246.The reported lot number matches the lot number on the returned original packaging box and for the returned sample.Returned for investigation was a 30cc 7.0fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number on the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging tray.Returned with the sample was the supplied 30cc inflation driveline tubing; no damage or abnormalities were noted.Upon return, the distal end of the super arrow-flex (saf) sheath was noted at approximately 23.3cm from the iabc distal tip; liquid blood was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.A kink to the iabc central lumen was noted at approximately 73cm from the iabc distal tip.Dried yellow media was noted on the hemostasis cuff and cath-guard.Dried blood was noted on the exterior surfaces of the returned iabc.A small amount of dried blood was noted within the iabc helium pathway.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 minute and then 30 seconds five separate times.The iabc central lumen was aspirated and flushed using a syringe.No abnormalities or debris were noted.The iabc was leak tested.A leak was immediately detected from the bladder membrane.Under microscopic inspection, a cut on the iabc bladder, consistent with contact from a sharp object, was noted at approximately 5.7cm to 6.5cm from the iabc distal tip.No other leaks were detected.A guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 73.2cm from the iabc distal tip, which is the location of the previously noted kink.The guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 11.5cm from the iabc luer, which is the location of the previously noted kink.The guidewire was able to advance through the central lumen.No blood or debris was noted.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.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, a puncture consistent with contact from a sharp object was found on the iabc bladder and could allow blood to enter the helium pathway.No other leaks were detected during functional testing.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the bladder leak.The root cause of the bladder leak is undetermined.The most probable potential cause of how the catheter came into contact with a sharp object is customer handling.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "patient suffered from acute myocardial infarction and was sent to the ccu for emergency treatment.After the operation, the iab catheter was inserted for assistance.Blood was found, after checking, it was found that the balloon was ruptured.As a result, the catheter was replaced at the same insertion site and worked as expected.There was no report of patient complications, serious injury or death.".

• Brand Name: REDIGUARD IAB: 7FR 30CC
• 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: 15575223
• Report Number: 3010532612-2022-00393
• Device Sequence Number: 12281277
• Product Code: DSP
• UDI-Device Identifier: 10801902145632
• UDI-Public: 10801902145632
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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 Expiration Date: 02/28/2024
• Device Model Number: IPN039779
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F22C0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown