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 Entrapment of Device (1212); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while in the intensive care unit the intra-aortic balloon (iab) was inserted via the patient's left femoral artery through a sheath.After five hours of intra-aortic balloon pump (iabp) therapy, during the evening hours, blood was noticed in the helium line and there was a helium loss alarm.The md had difficulty removing the iab from the patient.Medical / surgical intervention was required.The patient sustained an aortic tear.It was reported that the balloon was retrieved and the patient was doing well.Another iab was not inserted.Iabp therapy was interrupted.There was a reported patient complication (aortic tear).There was no reported patient death.The patient outcome is listed as patient was doing well.It was noted that the iabp used was the autocat2w.

Manufacturer Narrative

(b)(4).Additional information received via medwatch report (mw5061859) on 05/26/2016.Pt was a non-stemi from the (ed) emergency department taken to the cath lab after the cath a iab was placed and at 0500 blood was noted in the balloon catheter.No product was returned for evaluation.A device history record (dhr) 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 blood in the helium pathway is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported that while in the intensive care unit the intra-aortic balloon (iab) was inserted via the patient's left femoral artery through a sheath.After five hours of intra-aortic balloon pump (iabp) therapy, during the evening hours, blood was noticed in the helium line and there was a helium loss alarm.The md had difficulty removing the iab from the patient.Medical / surgical intervention was required.The patient sustained an aortic tear.It was reported that the balloon was retrieved and the patient was doing well.Another iab was not inserted.Iabp therapy was interrupted.There was a reported patient complication (aortic tear).There was no reported patient death.The patient outcome is listed as patient was doing well.It was noted that the iabp used was the autocat2w.

• 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: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5640312
• MDR Text Key: 44700389
• Report Number: 1219856-2016-00108
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18S15D0034
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• 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