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 Leak/Splash (1354); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while in the cath lab the user performed the zeroing but the fos was not detected.They performed a manual zeroing but the catheter did not work.They extracted the catheter and inserted a new one via the femoral artery.The iab was prepped successfully.The fos zeroed and the cal key was inserted.At this point they turned off and turned on the iapb that worked well for seven minutes.The iapb performed an alarm: "error pump".Suddenly the iab burst in artery without patient's complications.They extracted the catheter following standard procedures and inserted a third catheter of a different lot number with success.Final condition of the patient is fine.

Manufacturer Narrative

(b)(4) the serial number on the device is (b)(4).The device was returned in a sealed plastic pouch.The driveline tubing was returned connected to the short driveline tubing.Blood was noted within the driveline tubing, bladder membrane, and short driveline tubing.The teflon sheath was returned over the bladder membrane.Approximately 10.0cm of the bladder membrane was visible beneath the hub of the teflon sheath.Buckling was noted on the teflon sheath, and this is consistent with potential removal of the catheter through the sheath.No kinks were noted on the device.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 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 bladder thickness was measured at six points with measurements 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 28.0cm from the distal tip of the catheter.The teflon sheath was unable to be removed from the device without using a scalpel to cut the sheath body down.This can potentially cause damage to the bladder membrane.After removing the sheath body from the device by use of a scalpel, the iab was submerged in water and leak tested.A leak was immediately noticeable from bladder membrane.Under microscopic inspection, a cut consistent with contact from a sharp object was found approximately 1.8cm from the distal tip of the catheter.No abrasions were noted.No other leaks were found on the bladder membrane.A device history record (dhr) review was conducted for the lot 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 cut consistent with contact from a sharp object was found on the bladder membrane allowing blood to enter the helium pathway.No abrasions were noted.The root cause of the damage is undetermined.

Event Description

It was reported that while in the cath lab the user performed the zeroing but the fos was not detected.They performed a manual zeroing but the catheter did not work.They extracted the catheter and inserted a new one via the femoral artery.The iab was prepped successfully.The fos zeroed and the cal key was inserted.At this point they turned off and turned on the iapb that worked well for seven minutes.The iapb performed an alarm: "error pump".Suddenly the iab burst in artery without patient's complications.They extracted the catheter following standard procedures and inserted a third catheter of a different lot number with success.Final condition of the patient is fine.

• 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: 5981315
• MDR Text Key: 55790179
• Report Number: 1219856-2016-00221
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18S16F0006
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• 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