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 Material Rupture (1546)

Patient Problems Shock (2072); Respiratory Failure (2484)

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample not expected for return.

Event Description

It was reported that the event involved a patient in the cath lab.The (iab) intra-aortic balloon catheter was prepped, and the md inserted the iab into the patient's right femoral artery.After the pump inflated the balloon 2-3 times the pump alarmed with "high pressure." the md noted that blood was in the line / balloon the md reported that the balloon burst during use.At this time the md removed the iab and inserted another iab using the same insertion site.The insertion of the second iab was successful.There was a reported interruption / delay in iabp therapy.The patient is in the intensive care unit.Additional information received on 06/01/2016 there were no reported patient complications, death, or injury.Other, medical / surgical intervention was not required.It is unknown if the customer used an arrow pump for the procedure.The patient outcome is listed as ok.

Manufacturer Narrative

(b)(4).Returned for evaluation was a 40cc 8.0fr fos iab within a brown shipping box.The 40cc driveline tubing was returned for evaluation, and blood was noted within the tubing.Blood was noted within the bladder membrane.Dried blood was noted on the bifurcate.The distal end of the sheath was located approximately 27.0cm from the distal tip of the catheter.The bladder membrane was fully unwrapped.No kinks or bends were noted to the device upon initial visual inspection.The fos connector and cal key were examined.The gray fos connecter 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 bladder thickness was measured at six points with measurements ranging from 0.0054in-0.0064in and was within specification.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 fos and cal key were connected to the iabp.The pump displayed a "ll pl" status indicating a potential broken fiber.The fiber was found broken approximately 1.1cm from the distal tip.Other remarks: the iab was submerged in water and leak tested using the mdt-50.A leak was found approximately 1.5cm from the distal tip.Under microscopic inspection, a puncture consistent with contact from the broken fiber was found.A lab inventory guidewire was inserted through the distal tip of the catheter.Resistance was noted approximately 1.0cm from the distal tip.The guidewire could not advance.Some dried blood exited with the guidewire.The guidewire was inserted through the luer end of the catheter.Resistance was noted approximately 81.0cm from the luer end.The guidewire could not advance.No blood or debris exited with the guidewire.The blood clot at the tip was unable to be cleared.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 blood in helium pathway is confirmed.A puncture consistent with contact from the broken fiber was found near the distal tip of the catheter which likely allowed blood to enter the helium pathway.The root cause of the broken fiber is undetermined.

Event Description

It was reported that the event involved a patient in the cath lab.The (iab) intra-aortic balloon catheter was prepped, and the md inserted the iab into the patient's right femoral artery.After the pump inflated the balloon 2-3 times the pump alarmed with "high pressure." the md noted that blood was in the line / balloon the md reported that the balloon burst during use.At this time the md removed the iab and inserted another iab using the same insertion site.The insertion of the second iab was successful.There was a reported interruption / delay in iabp therapy.The patient is in the intensive care unit.Additional information received on 06/01/2016 there were no reported patient complications, death, or injury.Other, medical / surgical intervention was not required.It is unknown if the customer used an arrow pump for the procedure.The patient outcome is listed as ok.

• 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: 5743130
• MDR Text Key: 47999111
• Report Number: 1219856-2016-00128
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16B0028
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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