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

Catalog Number IAB-05840-U

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call that the md (attending on service) discussed with the clinical support specialist (css) that due to the patient (pt) being restless, the intra-aortic balloon (iab) had gotten pulled down/partially out of the pt and they had taken him into the lab to reposition the iab.The rn confirmed that at 0600, the first possible helium loss alarm occurred.By 0625 when she came on shift, the alarm was occurring nonstop and a cxr (chest x-ray) was taken and the tip was very low in the body.They then took the pt to the lab and upon readmission to the icu, there have been no further alarms and the pump is supporting the pt without incidence.The pt only had possible helium loss alarms when the iab had been misplaced by pt movement and have not recurred.The pt is going to the or for cabg (coronary artery bypass graft) between 11 and 12 local time today.The css asked the rn to relay the situation to the or staff and ask them if the iab is removed in the operating room to save it for return and send it in a red biohazard bag to the sicu (surgical intensive care unit) with the pt.The rn verbalized understanding of all and is going to watch the tubing for any further blood and has no further questions.On (b)(6) 2015 at 1036 est the css called into the sicu and spoke with the rn who is now caring for the pt.The rn reported no alarms overnight and the rn had none today.The pt is currently on 1:4 assist.At 1554 est the css called and spoke with the rn.The pt is currently on 1:4 and the plan is to remove the iab tomorrow.The pt has had no alarms and no blood in the driveline.

Manufacturer Narrative

(b)(4).Additional information: added lot# and expiration date and device manufacture date.Evaluation: no product was returned for evaluation.The specific serial number/lot number was not reported, but a device history record review was conducted for all the lot numbers/serial numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint of catheter migrated is not able to be confirmed.The root cause of the complaint is undetermined.

Event Description

It was reported via a hot line call that the md (attending on service) discussed with the clinical support specialist (css) that due to the patient (pt) being restless, the intra-aortic balloon (iab) had gotten pulled down/partially out of the pt and they had taken him into the lab to reposition the iab.The rn confirmed that at 0600, the first possible helium loss alarm occurred.By 0625 when she came on shift, the alarm was occurring nonstop and a cxr (chest x-ray) was taken and the tip was very low in the body.They then took the pt to the lab and upon readmission to the icu, there have been no further alarms and the pump is supporting the pt without incidence.The pt only had possible helium loss alarms when the iab had been misplaced by pt movement and have not recurred.The pt is going to the or for cabg (coronary artery bypass graft) between 11 and 12 local time today.The css asked the rn to relay the situation to the or staff and ask them if the iab is removed in the or to save it for return and send it in a red biohazard bag to the sicu (surgical intensive care unit) with the pt.The rn verbalized understanding of all and is going to watch the tubing for any further blood and has no further questions.On (b)(6) 2015 at 1036 est the css called into the sicu and spoke with the rn who is now caring for the pt.The rn reported no alarms overnight and the rn had none today.The pt is currently on 1:4 assist.At 1554 est the css called and spoke with the rn.The pt is currently on 1:4 and the plan is to remove the iab tomorrow.The pt has had no alarms and no blood in the driveline.

• Brand Name: ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA-AORTIC BALLOON PRODUCT
• 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: 5211148
• MDR Text Key: 31073776
• Report Number: 1219856-2015-00239
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: IAB-05840-U
• Device Lot Number: 18F15D0016
• Other Device ID Number: 00801902010759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2015
• 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