MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; INTRA-AORTIC BALLOON

Catalog Number IAB-06830-U

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample will not be returned for evaluation.

Event Description

It was reported that the rn from the icu was calling to report several high pressure alarms and having changed the volume from 30cc to 24cc per internal hospital educator.Ef (ejection fraction) on (b)(6) 2 016 was 10-15%.A 30cc intra-aortic balloon (iab) was placed in the cath lab without incidence along with a swanganz catheter on (b)(6) 2016 pending ohs (open heart surgery).The cabgx5 was done on (b)(6) 2016.After approximately two days of milrinone and epi, ef was now at 20-25%.Patient (pt) was intubated and lightly sedated; possible wean intra-aortic balloon pump (iabp) in the morning.Rn relayed there had been several high pressure alarms over the last couple of hours.The rn confirmed no visible kinking.Chest x-ray (cxr) was taken and they are awaiting the results.The clinical support specialist (css) had the rn send a screenshot.The css had the rn bring the cursor to the plateau in the waveform and it was reading 224 confirmed on the screenshot.The css and rn discussed how this showed the iab to be too occlusive in the aorta.The css and rn then decreased the volume to 20cc.The cxr came back and it showed the iab tip to be very low (6th intercostal avg).The pt continued to have good uo (urine output) every hour.The css suggested that they call the md and have the intra-aortic balloon (iab) repositioned to the 2/3 intercostal.Css and rn discussed the proper method for this.The css asked the rn to call back when the physician had repositioned the iab.At 0200 the rn text messaged the css and asked the css to call so her phone would be available for texting pictures if needed.When the css called the rn back, she found the iab had been repositioned.The css had the rn perform a flush to the central lumen as the ap (arterial pressure) waveform was a bit damped.After the flush the ap waveform was much better.The css then had the rn check the plateau pressure again and was able to increase the iab back to 100% fill at 30cc.The rn had a screenshot at 26cc after the central lumen flush and the waveforms looked appropriate.At 0800, the css text messaged the rn to see how the rest of the shift had been.She had no further issues and they are starting to wean the iab and further wean the gtts.It was noted that the intra-aortic balloon pump used was the iap-0500, s/n (b)(4).

Manufacturer Narrative

(b)(4).Evaluation: no product was returned for evaluation.The customer photos were reviewed; the high pressure alarm cannot be confirmed from the photos.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 high pressure alarm is not able to be confirmed.The root cause of the complaint is undetermined.

Event Description

It was reported that the rn from the icu was calling to report several high pressure alarms and having changed the volume from 30cc to 24cc per internal hospital educator.Ef (ejection fraction) on (b)(6) 2016 was 10-15%.A 30cc intra-aortic balloon (iab) was placed in the cath lab without incidence along with a swanganz catheter on (b)(6) 2016 pending ohs (open heart surgery).The cabgx5 was done on (b)(6) 2016.After approximately two days of milrinone and epi, ef was now at 20-25%.Patient (pt) was intubated and lightly sedated; possible wean intra-aortic balloon pump (iabp) in the morning.Rn relayed there had been several high pressure alarms over the last couple of hours.The rn confirmed no visible kinking.Chest x-ray (cxr) was taken and they are awaiting the results.The clinical support specialist (css) had the rn send a screenshot.The css had the rn bring the cursor to the plateau in the waveform and it was reading 224 confirmed on the screenshot.The css and rn discussed how this showed the iab to be too occlusive in the aorta.The css and rn then decreased the volume to 20cc.The cxr came back and it showed the iab tip to be very low (6th intercostal avg).The pt continued to have good uo (urine output) every hour.The css suggested that they call the md and have the intra-aortic balloon (iab) repositioned to the 2/3 intercostal.Css and rn discussed the proper method for this.The css asked the rn to call back when the physician had repositioned the iab.At 0200 the rn text messaged the css and asked the css to call so her phone would be available for texting pictures if needed.When the css called the rn back, she found the iab had been repositioned.The css had the rn perform a flush to the central lumen as the ap (arterial pressure) waveform was a bit damped.After the flush the ap waveform was much better.The css then had the rn check the plateau pressure again and was able to increase the iab back to 100% fill at 30cc.The rn had a screenshot at 26cc after the central lumen flush and the waveforms looked appropriate.At 0800 the css text messaged the rn to see how the rest of the shift had been.She had no further issues and they are starting to wean the iab and further wean the gtts.It was noted that the intra-aortic balloon pump used was the iap-0500, s/n (b)(4).

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: INTRA-AORTIC BALLOON
• 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: 5531753
• MDR Text Key: 41419157
• Report Number: 1219856-2016-00077
• 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,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F14G0078
• Other Device ID Number: 00801902003751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• 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: 44 YR