MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06840-U

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the arterial pressure (ap) waveform was very dampened and had a lot of artifact on the intra-aortic balloon (iab).The central lumen was flushed and the extra pressure tubing extensions on the central lumen were removed.The rn was not able to draw blood back or flush the central lumen.The central lumen on the iab clotted off.As a result, the rn connected an alternate arterial line and the waveform returned and was easy to read.The alternate arterial line was used for monitoring.The waveform is appropriate and the patient is meeting goals of therapy.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab central lumen occluded is not able to be confirmed.The root cause of the complaint 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.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the arterial pressure (ap) waveform was very dampened and had a lot of artifact on the intra-aortic balloon (iab).The central lumen was flushed and the extra pressure tubing extensions on the central lumen were removed.The rn was not able to draw blood back or flush the central lumen.The central lumen on the iab clotted off.As a result, the rn connected an alternate arterial line and the waveform returned and was easy to read.The alternate arterial line was used for monitoring.The waveform is appropriate and the patient is meeting goals of therapy.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9071172
• MDR Text Key: 182361177
• Report Number: 3010532612-2019-00331
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• PMA/PMN Number: K000729
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F19E0029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXTRACORPOREAL MEMBRANE OXYGENATION; EXTRACORPOREAL MEMBRANE OXYGENATION