MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-06840-U

Device Problem Gas/Air Leak (2946)

Patient Problem Myocardial Infarction (1969)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event involved a patient 172cm in height.While in the cath lab the iab was prepped and inserted via a sheath into the patient's left femoral artery.After insertion of the catheter and its use for about 30 minutes, "the balloon was broken." the pump (s/n (b)(4) alarmed "possible helium loss (2)".The iab was removed, catheter kinking occurred when removing the catheter.Another iab-06840-u was inserted successfully, into the same insertion site and there was no improvement.The patient was then treated with ecmo (extracorporeal membrane oxygenation), and still no improvement and the patient expired.The cardiologist reported that the device did not cause or contributed to the death of the patient.

Manufacturer Narrative

(b)(4) the sample was returned in a sealed ziplock bag the teflon sheath was returned on the bladder membrane.The teflon sheath was separated.The distal end of the extrusion of the teflon sheath was approximately 1.1cm from the iab distal tip.Buckling was noted on the sheath extrusion from approximately 8.7cm to 15.5cm from the iab distal tip.The buckling is consistent with attempting to remove the catheter through the sheath.The distal end of the remaining sheath hub was approximately 51.0cm from the iab distal tip.The bladder was found detached at the proximal end.The distal end of the outer lumen was approximately 26.6cm from the iab distal tip.The bladder was noted with two cuts at approximately 16.8cm from the iab distal tip.Each cut was approximately 4.4cm in length.Two cuts to the bladder membrane are confirmed and the appearance is consistent with contact with a sharp.A bend was noted at approximately 36.5cm from the iab distal tip.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." see other remarks section.Other remarks: 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.After removing the sheath from the catheter, the bladder was too damaged for further testing.An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed.A lab inventory 0.025in guidewire was back loaded through the iab distal tip.Resistance was noted at approximately 5.7cm and 51.7cm from the iab distal tip.The guidewire was able to advance through the central lumen while excreting blood out the iab luer.Blood exited on the guidewire.The guidewire was front loaded through the iab luer.Resistance was noted at approximately 24.6cm from the iab luer.The guidewire was able to advance through the central lumen while excreting blood out the iab distal tip.Blood exited on the guidewire.After clearing a blood clot, the catheter was successfully aspirated and flushed using a 60cc lab-inventory syringe.Blood was noted upon performing.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 helium loss alarm is not able to be confirmed.The iab bladder was returned too damaged to analyze.The balloon of the iab was returned covered with the teflon sheath indicating potential removal difficulty.The root cause of the complaint is undetermined.

Event Description

It was reported that the event involved a patient (b)(6) height.While in the cath lab the iab was prepped and inserted via a sheath into the patient's left femoral artery.After insertion of the catheter and its use for about 30 minutes, "the balloon was broken." the pump (s/n (b)(4)) alarmed "possible helium loss (2)".The iab was removed, catheter kinking occurred when removing the catheter.Another iab-06840-u was inserted successfully, into the same insertion site and there was no improvement.The patient was then treated with ecmo (extracorporeal membrane oxygenation), and still no improvement and the patient expired.The cardiologist reported that the device did not cause or contributed to the death of the patient.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• 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: 5844060
• MDR Text Key: 51193312
• Report Number: 1219856-2016-00164
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K000729
• 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: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F15M0035
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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: 51 YR
• Patient Weight: 70