MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. IAB: 7.5FR - 40 CC; INTRA-AROTIC BALLOON PRODUCTS

Catalog Number IAB-06840-U

Device Problem Occlusion Within Device (1423)

Patient Problem Cardiogenic Shock (2262)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

It was reported via a call from the cardiovascular unit rn to the clinical support specialist (css) on (b)(6) 2014 at 6:10 am (b)(6) that the rn was calling because the arterial pressure wave form from the iab was dampened.The intra-aortic balloon (iab) was inserted through the sheath via right femoral artery on (b)(6) 2014 without issue.When the css spoke with the rn, the rn stated that the arterial pressure waveform on the autocat2wave (s/n (b)(4)) was very poor and the readings on the pump were 213/213/213/213.The rn has tried to flush, re-zero, and reposition the patient but there was no change to the waveform or pressure readings.The css had the rn shake the transducer tubing to make sure changes could be seen and there was movement.The css had the rn disconnect the transducer set-up from the iab and connect it to the bedside monitor.Initially there was a little arterial pressure waveform but then it also began to dampen out and become a mean arterial pressure.The css had the rn aspirate the central lumen and the rn was unable to get any blood back.The css explained that the central lumen was clotting off and that they would need to have another arterial pressure line inserted or exchange the iab.They were planning to wean the patient today from the intra-aortic balloon pump (iabp).The patient was stable.The css also tried to see if there was an adequate pressure waveform from the side-port of the sheath, but it was very dampened.The central lumen of the iab had heparinized saline in the transducer set-up and the patient was also on a heparin drip.There were no pump strips generated or x-rays performed for review.There was no report of patient death, complications or injury.No medical/surgical intervention was required.There was no delay or interruption in therapy.The patient outcome is stable.Additional information received on (b)(4) 2014 stated the css believed they were gong to wean the patient the day the placed the call to the hot-line.The patient was stable.When the css explained that the central lumen was clotted off, the css told them that they would either need to replace the iab or get another arterial line to the pump in order to time the iab.The css didn't think they were planning to replace the iab since they were planning to wean the male patient off iabp therapy that day.The css guess is when the called the physician they would have just elected to go ahead and remove the iab at that time.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 7.5FR - 40 CC
• Type of Device: INTRA-AROTIC BALLOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, associate ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4120930
• MDR Text Key: 19090967
• Report Number: 1219856-2014-00134
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 07/28/2014
• 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