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 Device Alarm System (1012); Kinked (1339); Leak/Splash (1354)

Patient Problem Venipuncture (2129)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call.The critical care registered nurse (rn) has a patient who continued to have chest pain and intra-aortic balloon (iab) was inserted in the cath lab.Possible helium loss alarms began a short time ago and she has had 5 alarms about 3 minutes apart from each other.The helium driveline has no blood in it, there is no visible physical kink on the catheter and the patient is not having any ectopy.She has decreased the volume to 38 cc and the alarm has stopped.We then continued to discuss the possible causes.The patient's heart rate (hr) is between 60-65 bpm with a vvi (ventricle paced/sensed inhibited) pacer at 60 bpm.The balloon pressure waveform (bpw) is 123 and augmentation is 145 and we reviewed the relationship between the 2 pressures.As the patient began coughing, the alarm did recur once.The rn is going to discuss the volume change with the physician.The rn is going to switch to another console and we reviewed how to complete a mean arterial pressure (map) calibration.She verbalized understanding of all and has no further questions at this time.The css received a text from the rn that the alarm was happening again, now on the second console, and she requested a call back.She has gone down to 33 cc (80%) on volume.Strips attached.Sloping on bpw was reviewed and that it could be a partial kink on the iab.The patient's heart rate is the same and there still is no blood noted in the driveline.Leak test was performed and the iab did fail.Discussed removal and the cardiologist is willing to remove tomorrow.We discussed possible entrapment.The cardiologist was made aware and is going to come in and change the iab now.The css called the unit and spoke to the rn now taking care of the patient.The patient is stable and the cath lab staff is at bedside ready to take the patient down to exchange the iab.The current insertion is in the right femoral artery.We discussed the possibility of using the same site for the second iab or it may be a fresh stick on the left femoral.The iab was removed without incidence and the second iab was inserted in the left femoral artery.There was a reported delay and interruption in therapy but there was no reported patient death, injury or complications.

Manufacturer Narrative

(b)(4).Teleflex received the device for analysis.The reported complaint of blood in helium pathway is confirmed.The iab was returned separated in 2 sections; the iab central lumen and outer was found broken at the location of the catheter separation.The broken central lumen likely allowed blood to enter the helium pathway.The actual root cause of the broken central lumen and outer lumen is undetermined but based on the analysis of the returned device, it is likely due to patient movement.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.This issue will be monitored for any developing trends.(b)(4).

Event Description

It was reported via a hot line call.The critical care registered nurse (rn) has a patient who continued to have chest pain and intra-aortic balloon (iab) was inserted in the cath lab.Possible helium loss alarms began a short time ago and she has had 5 alarms about 3 minutes apart from each other.The helium driveline has no blood in it, there is no visible physical kink on the catheter and the patient is not having any ectopy.She has decreased the volume to 38cc and the alarm has stopped.We then continued to discuss the possible causes.The patient's heart rate (hr) is between 60-65bpm with a vvi (ventricle paced/sensed inhibited) pacer at 60bpm.The balloon pressure waveform (bpw) is 123 and augmentation is 145 and we reviewed the relationship between the 2 pressures.As the patient began coughing, the alarm did recur once.The rn is going to discuss the volume change with the physician.The rn is going to switch to another console and we reviewed how to complete a mean arterial pressure (map) calibration.She verbalized understanding of all and has no further questions at this time.The css received a text from the rn that the alarm was happening again, now on the second console, and she requested a call back.She has gone down to 33cc (80%) on volume.Strips attached.Sloping on bpw was reviewed and that it could be a partial kink on the iab.The patient's heart rate is the same and there still is no blood noted in the driveline.Leak test was performed and the iab did fail.Discussed removal and the cardiologist is willing to remove tomorrow.We discussed possible entrapment.The cardiologist was made aware and is going to come in and change the iab now.The css called the unit and spoke to the rn now taking care of the patient.The patient is stable and the cath lab staff is at bedside ready to take the patient down to exchange the iab.The current insertion is in the right femoral artery.We discussed the possibility of using the same site for the second iab or it may be a fresh stick on the left femoral.The iab was removed without incidence and the second iab was inserted in the left femoral artery.There was a reported delay and interruption in therapy but there was no reported patient death, injury or complications.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; chelmsford MA
• 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: 6610625
• MDR Text Key: 76659703
• Report Number: 1219856-2017-00111
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17B0020
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2017
• 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