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

Model Number IPN000262

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 05/29/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that helium loss alarms occurred.This began after the patient experienced severe abdominal pain and retching.The staff did not turn the intra-aortic balloon pump (iabp) back on after the alarms.There is no blood present and no kinks noted.Previous to the alarms the iabp had been supporting the patient without issue.The clinical support specialist (css) instructed the staff to turn the iabp back on and it immediately alarmed possible helium loss 3.The staff decreased intra-aortic balloon (iab) volume to 25cc, immediately alarmed after pumping resumed.The staff decreased to 20cc and again the iabp immediately alarmed after pumping resumed.As a result, the iab was removed.The patient is currently stable, md chose not to reinsert another iab.There was no report of patient complications, serious injury or death.The registered nurse reported that when the iab was removed there were "multiple kinks noted.".

Manufacturer Narrative

Qn# (b)(4).The product was not returned for investigation.The reported complaint of iab kinked is confirmed based on the customer photo submitted with the complaint report.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

Event Description

It was reported that helium loss alarms occurred.This began after the patient experienced severe abdominal pain and retching.The staff did not turn the intra-aortic balloon pump (iabp) back on after the alarms.There is no blood present and no kinks noted.Previous to the alarms the iabp had been supporting the patient without issue.The clinical support specialist (css) instructed the staff to turn the iabp back on and it immediately alarmed possible helium loss 3.The staff decreased intra-aortic balloon (iab) volume to 25cc, immediately alarmed after pumping resumed.The staff decreased to 20cc and again the iabp immediately alarmed after pumping resumed.As a result, the iab was removed.The patient is currently stable, md chose not to reinsert another iab.There was no report of patient complications, serious injury or death.The registered nurse reported that when the iab was removed there were "multiple kinks noted".

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12063367
• MDR Text Key: 263151387
• Report Number: 3010532612-2021-00161
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: 00801902002686
• Combination Product (y/n): N
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: IPN000262
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F20C0026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1