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

Catalog Number IAB-S840C

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) alarmed more than ten minutes later after insertion, indicating helium leak.There was blood in the three bifurcate.Processing according to the standard, the fault still existed while the catheter worked normally after replacing with a new one.Patient outcome reported as fine.There was no report of patient death, serious injury or complications.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab leak suspected is confirmed.During functional testing, a crack was found at the injection site of the iab bifurcate for the central lumen.This crack allowed a leak to occur at the injection site of the central lumen.The root cause of how the crack occurred 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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon pump (iabp) alarmed more than ten minutes later after insertion, indicating helium leak.There was blood in the three bifurcate.Processing according to the standard, the fault still existed while the catheter worked normally after replacing with a new one.Patient outcome reported as fine.There was no report of patient death, serious injury or complications.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8195910
• MDR Text Key: 131479388
• Report Number: 3010532612-2018-00390
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F17K0033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1