MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000261

Device Problems Signal Artifact/Noise (1036); Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) catheter had too much whip which created too much artifact.As a result, the user switched to our 40cc catheter and it worked fine.There was no report of patient injury or consequence.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that the iab "had too much whip which created too much artifact" is not able to be confirmed.A potential cause of the complaint is the iab size chosen for the patient.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon (iab) catheter had too much whip which created too much artifact.As a result, the user switched to our 40cc catheter and it worked fine.There was no report of patient injury or consequence.

• Brand Name: REDIGUARD IAB: 9FR 50CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9664871
• MDR Text Key: 184671685
• Report Number: 3010532612-2020-00017
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902010803
• UDI-Public: 00801902010803
• Combination Product (y/n): N
• PMA/PMN Number: K010330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

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 Model Number: IPN000261
• Device Catalogue Number: IAB-R950-U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1