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

Model Number IPN000263

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was inserted into the patient and the intra-aortic balloon pump (iabp) alarmed for "purge failure".The iabp was swapped out and a "purge failure" occurred on the new iabp.As a result, the staff changed to a new iab and the problem was resolved.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "purge failure alarm" is not confirmed.No damage or abnormalities were noted with the returned inflation driveline tubing and the iab catheter.The root cause of the complaint is undetermined.A device history record (dhr) review was not performed.There was no confirmed product failure with the returned sample.No further action is required.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted into the patient and the intra-aortic balloon pump (iabp) alarmed for "purge failure".The iabp was swapped out and a "purge failure" occurred on the new iabp.As a result, the staff changed to a new iab and the problem was resolved.There was no report of patient complications, serious injury or death.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9555040
• MDR Text Key: 183915244
• Report Number: 3010532612-2019-00464
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F18H0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 67