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

Model Number	IPN915324
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the procedure according to ifu, the physician found that the wire was bent and opened up a new kit to finish the procedure.Per the customer, it is unknown if the second iab was inserted at the same insertion site or a different site.The patient condition is reported as "fine".No harm or injury to the patient.No report of delay of therapy.
Additional Manufacturer Narrative
(b)(4).The serial number (b)(6) reported on the complaint report does not match the serial number on the returned sample.The serial number of the returned sample is jz10860.The reported lot number (18f21k0001) matches the lot number for the returned sample.Additional information obtained during a follow up indicates the returned sample is the correct iabc for this complaint.Returned for investigation was a 30cc 7.0fr rediguard intra-aortic balloon catheter (iabc) with an original packaging box that does not match the serial number on the returned iabc.The sample was returned in a shipping box and was packed in the original tray.Returned with the sample was the supplied 30cc inflation driveline tubing, ap tubing (short extension tubing and 60" tubing), and 60cc luer slip syringe; all components were visually inspected, and no abnormalities were noted.An unopened/sealed semi-finished insertion kit was returned with the sample; no abnormality was noted with the kit.Upon return, the peel away sheath was noted on the iabc.The bladder was noted in its original packaging location, within the tray; no abnormality was noted with the original packaging tray.The one-way valve was connected and tethered to the short driveline tubing.Two kinks were noted to the central lumen at approximately 12.5cm and 53.8cm from the iabc luer end and the central lumen was consistent with a flattened appearance.No blood was noted on the returned iabc.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.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 kinked is confirmed.Upon return, two kinks were noted to the iabc central lumen and were consistent with a flattened appearance.Resistance was noted upon loading a guidewire into the iabc central lumen.No other damage was noted to the central lumen.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 kinked/flattened central lumen.The root cause of the complaint is undetermined.A most probable potential cause 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 during the procedure according to ifu, the physician found that the wire was bent and opened up a new kit to finish the procedure.Per the customer, it is unknown if the second iab was inserted at the same insertion site or a different site.The patient condition is reported as "fine".No harm or injury to the patient.No report of delay of therapy.

• 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: 15896046
• Report Number: 3010532612-2022-00539
• Device Sequence Number: 12066885
• Product Code: DSP
• UDI-Device Identifier: 10801902161960
• UDI-Public: 10801902161960
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 11/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: IPN915324
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F21K0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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
• Patient Sex: Unknown