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

Catalog Number IAB-S840C

Device Problems Connection Problem (2900); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the intra-aortic balloon (iab) was placed into the patient and connected to the machine the staff noted a message appear for possible helium loss.The helium was replaced for another, but it was noted that there was no connection.As a result, the device was removed.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of iab leak suspected is not confirmed.The returned iab bladder was fully intact with no abnormalities noted.Although, the root cause of the complaint is undetermined the returned device passed visual and functional test specifications.No further action required at this time.

Event Description

It was reported that when the intra-aortic balloon (iab) was placed into the patient and connected to the machine the staff noted a message appear for possible helium loss.The helium was replaced for another, but it was noted that there was no connection.As a result, the device was removed.There was no report of patient complication or serious injury and 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: 8680089
• MDR Text Key: 147372258
• Report Number: 3010532612-2019-00167
• Device Sequence Number: 1
• Product Code: DSP
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F17L0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1