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

Catalog Number IAB-05840-LWS

Device Problems Complete Blockage (1094); No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the fiber optic sensor (fos) on the intra-aortic balloon (iab) was not working.The perfusionist tempted to reconnect the fos several times and it never clicked or connected with audible tones.The central lumen was also not giving a waveform.It was noted that the male portion of the pressure tubing was snapped off inside the metal central lumen connection.The pressure tubing was changed out however they were unable to get a waveform.As a result, the perfusionist connected the transducer from the sidearm of the sheath and got a waveform on the pump.The pump was pumping the entire time using the ekg only.The patient was supported as needed per the perfusionist.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.If the product is returned at a later date, a full investigation of the sample will be completed.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 fiber optic sensor (fos) on the intra-aortic balloon (iab) was not working.The perfusionist tempted to reconnect the fos several times and it never clicked or connected with audible tones.The central lumen was also not giving a waveform.It was noted that the male portion of the pressure tubing was snapped off inside the metal central lumen connection.The pressure tubing was changed out however they were unable to get a waveform.As a result, the perfusionist connected the transducer from the sidearm of the sheath and got a waveform on the pump.The pump was pumping the entire time using the ekg only.The patient was supported as needed per the perfusionist.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9251482
• MDR Text Key: 183740308
• Report Number: 3010532612-2019-00381
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F19A0029
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1