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

Model Number IPN000262

Device Problem Infusion or Flow Problem (2964)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) gave frequent high pressure alarms.The staff tried troubleshooting by straightening the pipeline, injecting air into the balloon with a large needle, reducing the balloon volume to 20cc, and adjusting the counterpulsation ration to 1:2 but the alarm still continued to appear.As a result, the intra-aortic balloon (iab) was replaced.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).Teleflex received the device for investigation.The report complaint of iab high pressure alarm is confirmed.During the investigation, a kink was noted to the outer lumen and numerous kinks were noted to the iabc.Upon functional testing, the pump alarmed for "high pressure" and the cause of the alarm is a result of the kinked/damaged outer lumen.The root cause of the complaint is undetermined, but a potential cause is customer handling.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.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 the intra-aortic balloon pump (iabp) gave frequent high pressure alarms.The staff tried troubleshooting by straightening the pipeline, injecting air into the balloon with a large needle, reducing the balloon volume to 20cc, and adjusting the counterpulsation ration to 1:2 but the alarm still continued to appear.As a result, the intra-aortic balloon (iab) was replaced.There was no report of patient complications, serious injury or death.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11842691
• MDR Text Key: 263459810
• Report Number: 3010532612-2021-00149
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: IPN000262
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F20M0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.; NI.
• Patient Age: 65 YR