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

Model Number IPN000263

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2022

Event Type  malfunction  

Event Description

It was reported that when the balloon was extracted from the packing box, it was found that the balloon was slightly kinked, so it was not smooth in the implantation process and could not be positioned in place.As a result, the balloon was immediately withdrawn and replaced with a new one.There was no report of patient complications, serious injury, or death.

Manufacturer Narrative

(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.

Event Description

It was reported that when the balloon was extracted from the packing box, it was found that the balloon was slightly kinked, so it was not smooth in the implantation process and could not be positioned in place.As a result, the balloon was immediately withdrawn and replaced with a new one.There was no report of patient complications, serious injury, or death.

Manufacturer Narrative

(b)(4).No serial number was reported however, a serial number was observed on the returned sample.The lot number recorded on the complaint report matches the lot number on the returned sample.Original packaging box was used for the returned sample.Returned for investigation was a 40cc 8.0fr 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 an original packaging box.Returned with the sample were the 40cc inflation driveline tubing, the data-scope inflation driveline tubing, a super arrow-flex (saf) sheath w/sidearm, a teflon sheath with dilator inserted, a pre-dilator, a scalpel, a long arterial pressure tubing, a detached peel-away sheath, and a 0.025in guidewire; a kink to the guidewire was noted at approximately 108.3cm from the distal end of the guidewire, no other visual damage or abnormalities were noted to the returned components.Upon return, the one-way valve was tethered and connected to the short driveline tubing.The iabc bladder was fully unwrapped.A kink to the iabc central lumen was noted at approximately 10.8cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0067in-0.0078in and was within specification.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 reported compliant of iab kinked is confirmed.A kink to the central lumen was noted during the visual inspection of the returned iab catheter, and resistance was noted at the location of the kink upon loading a guidewire into the iabc central lumen.Based on the device history record (dhr)review that was conducted for the lot number, no relevant findings were noted.The device passed all manufacturing specifications prior to release, the product met specification upon release; however, the received product did not meet specifications during the complaint investigation due to the kinked central lumen.The root cause of the kink is undetermined, but a most probable potential cause is customer handling.No further action required at this time.This will be monitored for any developing trends.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: 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: marling heaton ; 3015 carrington mill blvd; morrisville, MA 27560
• MDR Report Key: 14602377
• MDR Text Key: 293354487
• Report Number: 3010532612-2022-00210
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

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 Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F21J0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1