MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; INTRA-AORTIC BALLOON FIBER OPTIC SYS

Catalog Number IAB-05840-LWS

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while in the cath lab there was initial difficulty when removing the stylet during prepping, but there were no visible issues, kinks or problems.The doctor reported that during insertion in the sheath there was some noted resistance and blood return back into the membrane portion that was not inserted.When the doctor removed the intra-aortic balloon (iab) from the sheath, the tip was disconnected from the iab membrane.A second iab was placed without difficulty or issues.There was minimal delay in therapy to the patient.The second insertion was successful and the patient properly supported on the pump.There was no reported death or injuries.

Manufacturer Narrative

(b)(4).Device evaluation: returned for evaluation was a 40cc 8.0fr fos iab.A 40cc inflation driveline tubing was also returned.The iab distal tip was separated from the iab flex tip assembly and bladder membrane.The separated distal tip had some of the bladder membrane attached.The tip of the bladder membrane appeared ripped.The packaging tray yellow retention tube was approximately 53.5cm from the tip of the broken flex tip assembly.The one-way valve was tethered to the short driveline tubing.Blood was observed on the exterior of the bladder, bifurcate and on the interior of the bladder and outer lumen.The bladder was fully unwrapped.Bends were noted at approximately 27.9cm and 30.1cm from the broken iab flex tip.The returned spring wire guide (swg) was inserted within the iab with 41cm exposed from the iab luer and 50.7cm exposed from the broken iab flex tip.The fos connector and cal key were examined.The gray fos connecter was 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 damage was 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 displayed "ll" (low light) and "pl" (pressure limit), indicating a possible broken fiber.The fiber was found broken approximately 27cm from the broken iab flex tip.The fiber was also found broken at the separated distal tip.The leak test was unable to be performed due to the separated distal tip.The swg inserted within the iab could not be removed.As a result, the iab was cut down to determine the cause of the stuck swg.The iab was cut at approximately 70.5cm from the broken flex tip assembly.The swg was easily removed from the bifurcate/luer portion, but the swg remained stuck in the bladder portion.The iab was cut again at approximately 34.7cm and the swg still remained stuck in the bladder portion.The iab was cut again at 29cm and the swg remained stuck in the bladder portion.The iab was cut again at 27cm and the swg was easily removed from the bladder portion.The bend noted at 27.9cm may have caused the swg to become stuck.A device history record 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 balloon tip separated is confirmed by visual inspection.The distal tip was found broken from the flex tip assembly and separated from the bladder membrane.The swg remained stuck in the iab due to a bend on the central lumen.The distal tip separation and stuck swg due to a bend on the central lumen are consistent with insertion difficulty noted in the event details.The root cause of the separated distal tip is undetermined.

Event Description

It was reported that while in the cath lab there was initial difficulty when removing the stylet during prepping, but there were no visible issues, kinks or problems.The doctor reported that during insertion in the sheath there was some noted resistance and blood return back into the membrane portion that was not inserted.When the doctor removed the intra-aortic balloon (iab) from the sheath, the tip was disconnected from the iab membrane.A second iab was placed without difficulty or issues.There was minimal delay in therapy to the patient.The second insertion was successful and the patient properly supported on the pump.There was no reported death or injuries.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA-AORTIC BALLOON FIBER OPTIC SYS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5419533
• MDR Text Key: 37787502
• Report Number: 1219856-2016-00030
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F15J0044
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2015
• 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