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 Fluid/Blood Leak (1250)

Patient Problem Atherosclerosis (1728)

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported that the event involved a 160cm in height.While in open heart surgery the iab was inserted via the patients "ascending aorta." after ~10-15 min of counter-pulsation was initiated and during weaning of bypass the autocat2 console alarmed "helium loss." the md and perfusionist found blood in the helium tubing immediately and the pump was switched off and the iab was removed and replaced successfully.There was a 5 minute delay in iabp therapy.The patient expired 7 hours later.The md and perfusionist stated that the patient was extremely ill and the iab did not contribute to the patient's death.

Manufacturer Narrative

(b)(4).Returned for evaluation was a 40cc 8.0fr fos iab with the supplied return kit.The bladder membrane and bifurcate were wrapped in bubble wrap.Blood was noted within the bladder membrane and short driveline tubing.The short driveline tubing was cut at the bifurcate.The one-way valve was not returned with the device.No kinks or bends were noted to the central lumen upon return.The fos connector and cal key were examined.The gray fos connecter was found recessed 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 fos and cal key were connected to the iabp.The pump displayed an "eo" status indicating a potentially dirty fos connector.After cleaning the tip with isopropyl alcohol, the fos was tested again, and the fos status was "ok".See other remarks section.Other remarks: the iab was submerged in water and leak tested using the mdt-50.A leak was found approximately 37.5cm from the distal tip on the outer lumen of the device.Under microscopic inspection, a puncture consistent with contact from a sharp object was found on the outer lumen.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 a sharp object was found on the outer lumen which likely allowed blood to enter the helium pathway.The root cause of the damage is undetermined.

Event Description

It has been reported that the event involved a (b)(6) cm in height.While in open heart surgery the iab was inserted via the patients "ascending aorta." after approximately 10-15 min of counter-pulsation was initiated and during weaning of bypass the autocat2 console alarmed "helium loss." the md and perfusionist found blood in the helium tubing immediately and the pump was switched off and the iab was removed and replaced successfully.There was a 5 minute delay in iabp therapy.The patient expired 7 hours later.The md and perfusionist stated that the patient was extremely ill and the iab did not contribute to the patient's death.

• 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: 5746317
• MDR Text Key: 48098594
• Report Number: 1219856-2016-00139
• 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: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18R14M0026
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2014
• 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: 64 YR
• Patient Weight: 74