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 Difficult To Position (1467); Unable to Obtain Readings (1516)

Patient Problems Arteriosclerosis (1722); Cardiac Arrest (1762)

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event involved a 170 cm in height patient in the icu and coded.While in surgery before the iab was inserted into the patient, the fiberoptic was zeroed appropriately, green icon activated.As the surgeon inserted the iab into the patient's right femoral artery sheathless, the green icon turned to black and blue.An error message appeared that said 'low input signal.' the surgeon continued with the insertion but was unsure of its position so he removed the balloon.Per the perfusionist, "we inserted another balloon, but when we tried to zero the fiberoptic, we got a message that said 'already zeroed.' we continued to use that balloon and it worked fine." there was no reported patient death, injury or complications.Medical / surgical intervention was not required.X-rays were performed and the placement of the iab was good.There was a delay / interruption in iabp therapy of 5 minutes.No harm to the patient reported.The patient outcome is listed as alive.The second iab was inserted into the same insertion site.Indication of use: post-op instability.

Manufacturer Narrative

Qn#(b)(4).Returned for evaluation was a 40cc 8.0fr iab fos in the supplied return kit.There was dried blood was noted on the bladder membrane and bifurcate.The catheter was returned withdrawn through the sheath, and the distal area of the catheter was covered by the sheath.Approximately 20.0cm of the balloon was visible outside of the sheath.A bend was noted on the central lumen approximately 23.0cm from the distal tip of the catheter.A bend was also noted at the base of the sheath hub approximately 70.0cm from the luer end of the device.The bladder membrane appeared fully unwrapped.The fos connector and cal key were examined.The gray fos connector was properly seated 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 abnormalities were 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.The pump status was ll pl indicating a potential broken fiber.The fiber was noted broken approximately 23cm from the distal tip of the catheter.See other remarks section.Other remarks: upon attempted removal of the sheath from the catheter, the central lumen cracked and broke approximately 7.5cm from the distal tip of the catheter.A scalpel was used to remove the extrusion of the sheath from the sheath hub, and after removal of the extrusion, the balloon was found bunched up.The condition of the bladder membrane beneath the sheath made it impossible to remove the sheath without causing further damage to the device.The device was submerged under water and leak tested.The device failed leak test.A cut consistent with contact from the previously used scalpel was found on the bladder membrane approximately 5.0cm from the distal tip of the catheter.The ifu states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." 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 fos signal lost is confirmed.The fiber was found broken; therefore, the fos connector was not able to establish a light path with the pump.The root cause of the fiber breaking is undetermined.

Event Description

It was reported that the event involved a (b)(6) in height patient in the icu and coded.While in surgery before the iab was inserted into the patient, the fiberoptic was zeroed appropriately, green icon activated.As the surgeon inserted the iab into the patient's right femoral artery sheathless, the green icon turned to black and blue.An error message appeared that said 'low input signal.' the surgeon continued with the insertion but was unsure of its position so he removed the balloon.Per the perfusionist, "we inserted another balloon, but when we tried to zero the fiberoptic, we got a message that said 'already zeroed.' we continued to use that balloon and it worked fine." there was no reported patient death, injury or complications.Medical / surgical intervention was not required.X-rays were performed and the placement of the iab was good.There was a delay / interruption in iabp therapy of 5 minutes.No harm to the patient reported.The patient outcome is listed as alive.The second iab was inserted into the same insertion site.Indication of use: post-op instability.

• 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: 5803193
• MDR Text Key: 49953238
• Report Number: 1219856-2016-00159
• 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: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• 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: 18F16E0053
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• 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
• Patient Age: 79 YR
• Patient Weight: 65