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

Model Number	IPN000261
Medical Device Problem Codes	Signal Artifact/Noise (1036); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9664871
• Report Number: 3010532612-2020-00017
• Device Sequence Number: 2791487
• Product Code: DSP
• UDI-Device Identifier: 00801902010803
• UDI-Public: 00801902010803
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K010330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: IPN000261
• Device Catalogue Number: IAB-R950-U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1