MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 8 FR - 40 CC FOS; IAB- INTRA AORTIC BALLOON FOS SYSTEM

Catalog Number IAB-05840-LWS

Device Problems Material Puncture/Hole (1504); Communication or Transmission Problem (2896)

Patient Problem Cardiomyopathy (1764)

Event Date 04/17/2015

Event Type  malfunction  

Event Description

It was reported that the event involved a pt admitted stable, alert and communicating with (ccl) cardiac cath lab staff throughout procedure.According to the ccl (num) nurse unit manager an (aib) intra-aortic balloon catheter was inserted in the ccl on (b)(6) 2015.All iab catheters are placed in ccl prior to being transferred to surgery.Per the num the iab was inserted at 08:45 am by a consultant cardiologist.The green bulb indicated that the fos was zeroed prior to insertion.The num stated it took a few attempts to slide fos key correctly into position.The iab was inserted via competitor's 8fr, 11cm percutaneous sheath and a competitor's 0.025" x 145cm.3mm.Guide wire.The cardiologist reported to num that the insertion was smooth, no complications, and catheter position confirmed under x-ray.Counterpulsation commenced approx at 09:10 am, a second (rn registered nurse came in and noted a blue fos bulb (fiberoptix iab not zeroed prior to insertion), tried to manual re-zero to map, the rn stated the fos bulb flicking from white (fiberoptix iab value manually adjusted) to blue (fiberoptix iab not zeroed prior to insertion).They were unable to get fos waveform.The rn disconnected the iab catheter central lumen line from (non-pressurized) heparin saline bag and connected to transducer; unable to get ap waveform, using the iab pump ecg for counterpulsation the rn stated throughout ap troubleshooting pump was "pumping fine" on ecg, no alarms, pt stable and talking, the bpw waveform looked like a chair.Blood noticed in helium drive line - speckled appearance.No alarms reported.The catheter position was rechecked by the cardiologist on image intensification.At 09:10, the decision made to cease counterpulsation due to blood in helium drive line.No alarms reported.The pump was switched off for approx 1-2 min prior to arrival of perfusionist.The decision made to recommence counterpulsation for transfer of pt to operating theatre.Pump turned on, alarms (query type) triggered on start up, and continued alarming until pt was transferred out of ccl to operating theatres.No strip printouts noted, num thought the pump was out of paper.(per telefelx rep "questioned to determine if clinicians had to keep restarting pump on alarm conditions being triggered - answer not available at time of report") at this time the pt is alert, stable and talking at point of transfer out of ccl to operating theatre.Per the perfusionist and the (ct) cardio-thoracic surgeon.The transfer took approx 10 mins.Pt arrived in operating theatre at approx 11:00 am.On arrival iabp alarming, increasing blood in helium drive line, ct surgeon ceased counterpulsation immediately.The first iab and insertion sheath was removed and retained.A second arrow iab-05840-lws - serial number unable to be confirmed as catheter and packaging discarded was inserted over a guide wire with a new sheath.The second catheter was attached to the same pump console as was used in cath lab serial number (b)(4) - arrow autocat 2 wave iabp, fos was zeroed.The iab exchange was performed by ct surgeon using arrow insertion kit tray under (tee) trans-esophagea; echocardiography guidance.Some repositioning performed - catheter pulled out approx 1 cm, which ct surgeon did without issue.The iabc catheter tip position confirmed on tee to be in correct position.The iab catheter was sutured in 4 points as both ct surgeon and anesthetist happy with catheter tip position.Counterpulsation recommenced approx 45 minutes after pt arrival in anesthetic bay.Cardiac surgery reported to be uneventful, routine procedure.The counterpulsation throughout entire cardiac surgery was uneventful, no alarms, no iabp issues to report.The pt was transferred to icu around 3:00 pm in stable condition.See mdr 1219856-2015-00101 for next event that occurred with this pt.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 8 FR - 40 CC FOS
• Type of Device: IAB- INTRA AORTIC BALLOON FOS SYSTEM
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: anne rosenberger, clinical spe ; 2400 bernville rd; reading, PA 19605 ; 6104783117
• MDR Report Key: 4771424
• MDR Text Key: 17541005
• Report Number: 1219856-2015-00099
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05840-LWS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR