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 Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported via a hotline call within 3 hours from inserting the iab vai a sheath.The nurse at the bedside stated to the clinical support specialist (css) that they had a patient on the autocat2 wave intra-aortic balloon pump (a2w), and they did not have any ap waveform.The nurse stated the fos was not connected and neither was the transducer.The css told the nurse that they could connect the fos, and the css would talk the nurse through the calibration procedure.The nurse gave the phone to a cardiology fellow and he said he did not want to connect the fos, and would not give the css a reason why.The css asked the fellow to at least connect the central lumen transducer to the pump and he handed the phone back to the nurse.The nurse did not know what the css was referring to when she said the "central lumen and transducer." the css asked the nurse to call the perfusionist and ask for help, since the css knows that they are in the hospital and recently had training.The nurse thanked the css and hung up.The (b)(4) cdt: the css called the chief perfusionist on his cell, and he had not heard from the unit, but he would go there right away and help them.The (b)(4) cdt: a call came in from the answering service from the ccu.They had the fos connected and the central lumen/transducer.They were able to get a waveform on the pump, but it was not showing any augmentation.They were getting high pressure and helium loss alarms approx.Every 30 seconds.The css asked if they had anything in the helium drive line tubing and they said "just moisture." the css then asked if anyone had facetime capabilities, and the chief said yes, he would try to facetime with the css.The connection was not great, but the css was able to see the connections of the transducer and fos.They were able to calibrate the fos.They still could not see any augmentation on the ap waveform.The css asked them to show her the helium drive line tubing.There was approximately a 1 inch "bubble" of pink condensation.The css told them they had a hole in the iab and they needed to leave the pump off, and remove the iab.They were very reluctant and wanted to know how to get the moisture out of the pump.The css told them they could not get the moisture out, and the iab needed to come out asap and to save it and send the pump to biomed to be checked.They said they weren't sure they were going to do that and would not tell the css any additional information.The css reiterated that the iab membrane was compromised, and that helium was leaking into the patient as well as blood backing up into the machine.The css also told them they should get the catheter out before it became entrapped.The css was speaking directly to the cardiology fellow.The fellow said "ok" and they said they would handle it from there.They were not able to give the css a serial number on the pump or catheter.

Manufacturer Narrative

(b)(4).Additional information received on 09/19/2016: per the clinical support specialist (css), the iab catheter was not saved and the patient was discharged to go home, there was no more information given to the css.The product was not returned for evaluation.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in the helium pathway is confirmed based on the information and video provided to the css.The product was not returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported via a hotline call within 3 hours from inserting the iab vai a sheath.The nurse at the bedside stated to the clinical support specialist (css) that they had a patient on the autocat2 wave intra-aortic balloon pump (a2w), and they did not have any ap waveform.The nurse stated the fos was not connected and neither was the transducer.The css told the nurse that they could connect the fos, and the css would talk the nurse through the calibration procedure.The nurse gave the phone to a cardiology fellow and he said he did not want to connect the fos, and would not give the css a reason why.The css asked the fellow to at least connect the central lumen transducer to the pump and he handed the phone back to the nurse.The nurse did not know what the css was referring to when she said the "central lumen and transducer." the css asked the nurse to call the perfusionist and ask for help, since the css knows that they are in the hospital and recently had training.The nurse thanked the css and hung up.At 1255 cdt: the css called the chief perfusionist on his cell, and he had not heard from the unit, but he would go there right away and help them.At 1336 cdt: a call came in from the answering service from the ccu.They had the fos connected and the central lumen/transducer.They were able to get a waveform on the pump, but it was not showing any augmentation.They were getting high pressure and helium loss alarms approx.Every 30 seconds.The css asked if they had anything in the helium drive line tubing and they said "just moisture." the css then asked if anyone had facetime capabilities, and the chief said yes, he would try to facetime with the css.The connection was not great, but the css was able to see the connections of the transducer and fos.They were able to calibrate the fos.They still could not see any augmentation on the ap waveform.The css asked them to show her the helium drive line tubing.There was approximately a 1 inch "bubble" of pink condensation.The css told them they had a hole in the iab and they needed to leave the pump off, and remove the iab.They were very reluctant and wanted to know how to get the moisture out of the pump.The css told them they could not get the moisture out, and the iab needed to come out asap and to save it and send the pump to biomed to be checked.They said they weren't sure they were going to do that and would not tell the css any additional information.The css reiterated that the iab membrane was compromised, and that helium was leaking into the patient as well as blood backing up into the machine.The css also told them they should get the catheter out before it became entrapped.The css was speaking directly to the cardiology fellow.The fellow said "ok" and they said they would handle it from there.They were not able to give the css a serial number on the pump or catheter.

• 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: 5952750
• MDR Text Key: 54893167
• Report Number: 1219856-2016-00204
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05840-LWS
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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