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

Catalog Number IAB-S730C

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was inserted and after the catheter was inserted the intra-aortic balloon pump (iabp), machine alarmed with "vacuum failure" and would not work.The iabp was exchanged and the "vacuum failure" alarm occurred again.As a result, the physician changed to a new iab and the problem was solved.Additional information received.The reported alarm is "purge failure".There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of leak suspected is confirmed.Upon leak testing, an external leak is confirmed from the iab bifurcate bushing adhesive.The root cause of the leak is undetermined.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.A non-conformance has been initiated to further investigate the root cause.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted and after the catheter was inserted the intra-aortic balloon pump (iabp), machine alarmed with "vacuum failure" and would not work.The iabp was exchanged and the "vacuum failure" alarm occurred again.As a result, the physician changed to a new iab and the problem was solved.Additional information received.The reported alarm is "purge failure".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: 9111163
• MDR Text Key: 159863834
• Report Number: 3010532612-2019-00336
• 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: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F19A0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 61