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

Catalog Number IAB-05840-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problem Mitral Insufficiency (1963)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

It was reported that the md inserted the intra-aortic balloon (iab) while in the operating room.The pt was now in the intensive care unit and had received approximately 2 to 3 hours of intra-aortic balloon pump (iabp) therapy.The staff saw blood in the catheter.The iabp therapy was stopped.There was a reported delay / interruption in iabp therapy.Ref mdr # 1219856-215-00042 for the second incident involving the same pt.

Manufacturer Narrative

Qn #(b)(4).Sample will not be returned for eval.

• Brand Name: IAB: 8 FR - 40 CC FOS
• Type of Device: INTRA-AORTIC BALLOON FIBEROPTIC SYST
• Manufacturer (Section D): ARROW INTL. INC.; reading PA
• Manufacturer (Section G): ARROW INTL. INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory assoc ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4563783
• MDR Text Key: 5458287
• Report Number: 1219856-2015-00041
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F15A0005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2015
• 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
• Patient Age: 71 YR
• Patient Weight: 67