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); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the intra-aortic balloon (iab) was inserted into the patient, the balloon could not be inflated.The pump displayed "iab catheter restriction".As a result, the iab was removed, and another attempt was made with a new kit successfully.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab would not inflate completely is not confirmed.The returned iab bladder was fully intact with no damage 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 inserted into the patient, the balloon could not be inflated.The pump displayed "iab catheter restriction".As a result, the iab was removed, and another attempt was made with a new kit successfully.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: 8217403
• MDR Text Key: 132080035
• Report Number: 3010532612-2018-00407
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F18D0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DOBUTAMINE GTT; DOBUTAMINE GTT; DOBUTAMINE GTT
• Patient Age: 69 YR
• Patient Weight: 85