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

Catalog Number IAB-05840-LWS

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample not returned for investigation.

Event Description

It was reported via a hotline call from the perfusionist for the cardiovascular intensive care unit (cvicu) regarding a patient that has a 40cc lws iab that was placed in the or.The perfusionist stated that they had a great arterial pressure (ap) waveform initially, but that the signal was totally lost about 30 minutes after that.The perfusionist is not sure if it was zeroed prior to insertion and is calling for help troubleshooting this.The clinical support specialist (css) first verified that the pump (s/n (b)(4)) is currently pumping, and there have been no delays in therapy.The pump is in autopilot using weissler timing method.The css then had the perfusionist check the fos lightbulb, which is black (fiberoptix iab not corrected).The fos status codes are ll (low light return) and pl (fos is measuring outside of pressure range).The css then had the perfusionist check the tip of the fos connector, and it is not recessed.The css had the perfusionist attempt to reconnect a few times with no change.The css then explained that they will not be able to use the fos.The css then had the perfusionist check the central lumen, because they are also not getting any waveform from the xducer.They were not able to flush, nor aspirate anything from there.The css explained that the central lumen is clotted, and they should cap that and mark it.The css and perfusionist had a discussion about using an alternate ap source, and that a radial a-line would be the best now.For now they are transducing the sidearm of the sheath, and the pump is providing good therapy for the patient.The perfusionist thanked the css for the help.The css asked the perfusionist to have the iab saved after removal for return.Patient is stable on the balloon pump.

Manufacturer Narrative

(b)(4).No product was returned for evaluation.According to the event details the iab was used in transducer mode from the radial arterial line after the fos waveform disappeared and the central lumen was unable to provide a waveform.The css call was successful.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of central lumen occluded is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported via a hotline call from the perfusionist for the cardiovascular intensive care unit (cvicu) regarding a patient that has a 40cc lws iab that was placed in the or.The perfusionist stated that they had a great arterial pressure (ap) waveform initially, but that the signal was totally lost about 30 minutes after that.The perfusionist is not sure if it was zeroed prior to insertion and is calling for help troubleshooting this.The clinical support specialist (css) first verified that the pump (s/n (b)(4)) is currently pumping, and there have been no delays in therapy.The pump is in autopilot using weissler timing method.The css then had the perfusionist check the fos lightbulb, which is black (fiberoptix iab not corrected).The fos status codes are ll (low light return) and pl (fos is measuring outside of pressure range).The css then had the perfusionist check the tip of the fos connector, and it is not recessed.The css had the perfusionist attempt to reconnect a few times with no change.The css then explained that they will not be able to use the fos.The css then had the perfusionist check the central lumen, because they are also not getting any waveform from the xducer.They were not able to flush, nor aspirate anything from there.The css explained that the central lumen is clotted, and they should cap that and mark it.The css and perfusionist had a discussion about using an alternate ap source, and that a radial a-line would be the best now.For now they are transducing the sidearm of the sheath, and the pump is providing good therapy for the patient.The perfusionist thanked the css for the help.The css asked the perfusionist to have the iab saved after removal for return.Patient is stable on the balloon pump.

• 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: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5846577
• MDR Text Key: 51164703
• Report Number: 1219856-2016-00180
• 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: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16B0036
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• 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