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 Leak/Splash (1354); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while in the cath lab the catheter was placed via a sheath into the patient's femoral artery carefully with the previously outlined steps.The zero and fiberoptix calibration were ok, and green light (fiberoptix iab zero'd prior to insertion) was obtained.During the procedure the console gave a helium leak alarm.The techs checked all points for a potential cause and found none.Perfusion was called and found no potential cause either.The console was changed due to frequency of alarm, blue light (fiberoptix iab not zero'd prior to insertion) was obtained as expected on second console.Soon after, the helium loss alarmed again.The team decided to switch out the catheter.There were no visible signs of damage to the balloon or line.The second fiberoptix balloon was inserted with the second console, and has no issues or alarms.There was no reported patient death, injury or complications.There was a delay / interruption in iabp therapy for the time frame required to retrieve, prep, and insert the second iab successfully.

Manufacturer Narrative

(b)(4).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.Ifu states: "using current hospital protocol, connect pressure tubing extension to a prepared standard arterial pressure monitoring assembly which delivers 3 cc of pressurized flush per hour." this action is to maintain the patency of the arterial line.Conclusion: the reported complaint of helium loss alarm is confirmed.An external leak is confirmed from the iab bifurcate around the fos adhesive.The root cause of how the leak occurred is undetermined.Teleflex will monitor for any developing trends.Other remarks:.

Event Description

It was reported that while in the cath lab the catheter was placed via a sheath into the patient's femoral artery carefully with the previously outlined steps.The zero and fiberoptix calibration were ok, and green light (fiberoptix iab zero'd prior to insertion) was obtained.During the procedure the console gave a helium leak alarm.The techs checked all points for a potential cause and found none.Perfusion was called and found no potential cause either.The console was changed due to frequency of alarm, blue light (fiberoptix iab not zero'd prior to insertion) was obtained as expected on second console.Soon after, the helium loss alarmed again.The team decided to switch out the catheter.There were no visible signs of damage to the balloon or line.The second fiberoptix balloon was inserted with the second console, and has no issues or alarms.There was no reported patient death, injury or complications.There was a delay / interruption in iabp therapy for the time frame required to retrieve, prep, and insert the second iab successfully.

• 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: 6103176
• MDR Text Key: 59909490
• Report Number: 1219856-2016-00248
• 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: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16F0042
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• 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