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 Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call.The rn for the cath lab is calling because the chief of perfusion asked that she let us know about their difficulty due to "repeated problems as stated by the chief of perfusion" the rn stated that they inserted the intra-aortic balloon (iab) and on the pump (40101w) and they had persistent "low helium / kink" alarms.The rn attempted changing the tank, etc.Without resolution.There was no blood or kinks noted in the tubing.They were going to try another pump, but the doctor chose to remove the intra-aortic balloon (iab) (the iab serial number unavailable).A second iab was inserted via same site and a new pump was also used.

Manufacturer Narrative

(b)(4).The device was returned for evaluation, a 40cc 8.0fr fos iab in its supplied return kit.Small areas of dried blood were noted on the bladder membrane, but not within.The one-way valve was tethered to the short fiber-optix sensor (fos) driveline tubing.The bladder membrane was fully unwrapped.No kinks, damage, or abnormalities were noted on the device.The connector and cal key were examined.The gray fos connecter was seated properly in the housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined and no damage was noted.The cal key was intact.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.The cal key and fos were connected to the iabp.The cal key was recognized, but the fos was not recognized.The fos status was "ll pl" indicating a potentially broken fiber.The fiber was found broken approximately 1.1cm from the distal tip of the catheter.The iab was submerged in water and leak tested.The device passed leak test.No holes or leaks were noted.See other remarks section.Other remarks: a lab inventory guidewire was inserted through the distal tip of the catheter.No resistance was noted.The guidewire was able to fully advance.The guidewire was inserted through the luer end of the device, and no resistance was noted.The guidewire was able to fully advance.The iab was connected to the iabp and inserted into the t-tube.The t-tube was pressurized to 100mmhg.The pump was run for 30 minutes with no alarms noted.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 the pump alarming for low helium and kinks is not confirmed.No kinks or bends were noted on the iab upon return.The iab was also pump tested and no alarms occurred; however, the fiber was found broken, and the iab could not establish a light path with the pump.The root cause of the complaint is undetermined.We will continue to monitor for similar complaints.

Event Description

It was reported via a hot line call.The rn for the cath lab is calling because the chief of perfusion asked that she let us know about their difficulty due to "repeated problems as stated by the chief of perfusion" the rn stated that they inserted the intra-aortic balloon (iab) and on the pump (40101w) and they had persistent "low helium / kink" alarms.The rn attempted changing the tank, etc.Without resolution.There was no blood or kinks noted in the tubing.They were going to try another pump, but the doctor chose to remove the intra-aortic balloon (iab) (the iab serial number unavailable).A second iab was inserted via same site and a new pump was also used.

• 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: 6110301
• MDR Text Key: 60244198
• Report Number: 1219856-2016-00256
• 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: 10/22/2016

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: 05/31/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16E0005
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2016
• 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