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

Catalog Number IAB-05840-LWS

Device Problems Occlusion Within Device (1423); Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device was discarded by the staff.

Event Description

It was reported via a hotline call to the clinical support specialist (css) from a perfusionist in the operating room (or) regarding an intra-aortic balloon (iab) that had been inserted prior to surgery.The fiber optix sensor (fos) never made a connection on two separate pumps.There was no arterial pressure (ap) waveform on the pump and the pump was working with electrocardiography (ecg) only.The perfusionist was calling to troubleshoot the fos and the ap waveform.The clinical support specialist had the perfusionist attempt to disconnect and reconnect the fos without success.The perfusionist stated she was positive the fos slide was in the correct position and all the way in but she never heard the tones.The perfusionist said the md inserted the iab via a sheath into the patients femoral artery and they have a radial arterial line (a-line)on the anesthesia monitor but not on the pump.The css had the perfusionist confirm that the transducer was connected to the pump, and then attempted to zero, without success.The perfusionist changed the cable and the transducer and was not able to get a waveform at all.The perfusionist stated that, she thought it was flushing but couldn't be sure.The css asked the perfusionist to attempt to draw blood from the central lumen and they could not.It was determined that the central lumen had clotted and they will use an alternate a-line for the patient.The css discussed slaving the a-line and the "phono to phono cable" did not fit the output jack on the monitor.The css told the perfusionist to see if the sidearm of the sheath was patent; however it too had clotted.The perfusionist was going to ask the anesthesiologist to insert another a-line after the case.At 1426 cst: the perfusionist called the css directly and stated the case was completed without complications.The perfusionist wanted to know if she could attempt to calibrate the fos now.The css told her she could but that the css didn't expect it to work and it did not work.The perfusionist placed a huge sign on the pump to save the catheter and return it to her when it is removed.Length of time prior to the event: less than 15 minutes.The patient was supported as expected at end of the call.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for evaluation therefore the reported complaint of "central lumen had clotted" 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 will continue to monitor for developing trends.

Event Description

It was reported via a hotline call to the clinical support specialist (css) from a perfusionist in the operating room (or) regarding an intra-aortic balloon (iab) that had been inserted prior to surgery.The fiber optix sensor (fos) never made a connection on two separate pumps.There was no arterial pressure (ap) waveform on the pump and the pump was working with electrocardiography (ecg) only.The perfusionist was calling to troubleshoot the fos and the ap waveform.The clinical support specialist had the perfusionist attempt to disconnect and reconnect the fos without success.The perfusionist stated she was positive the fos slide was in the correct position and all the way in but she never heard the tones.The perfusionist said the md inserted the iab via a sheath into the patients femoral artery and they have a radial arterial line (a-line)on the anesthesia monitor but not on the pump.The css had the perfusionist confirm that the transducer was connected to the pump, and then attempted to zero, without success.The perfusionist changed the cable and the transducer and was not able to get a waveform at all.The perfusionist stated that, she thought it was flushing but couldn't be sure.The css asked the perfusionist to attempt to draw blood from the central lumen and they could not.It was determined that the central lumen had clotted and they will use an alternate a-line for the patient.The css discussed slaving the a-line and the "phono to phono cable" did not fit the output jack on the monitor.The css told the perfusionist to see if the sidearm of the sheath was patent; however it too had clotted.The perfusionist was going to ask the anesthesiologist to insert another a-line after the case.At 1426 cst: the perfusionist called the css directly and stated the case was completed without complications.The perfusionist wanted to know if she could attempt to calibrate the fos now.The css told her she could but that the css didn't expect it to work and it did not work.The perfusionist placed a huge sign on the pump to save the catheter and return it to her when it is removed.Length of time prior to the event: less than 15 minutes.The patient was supported as expected at end of the call.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6356496
• MDR Text Key: 68372791
• Report Number: 1219856-2017-00035
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

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 Expiration Date: 08/31/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16H0014
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1