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

Catalog Number IAB-05840-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problem Mitral Insufficiency (1963)

Event Date 02/17/2015

Event Type  Injury  

Event Description

Reference mdr #1219856-2015-00041 for the first incident involving the same patient.It was reported that a new catheter was inserted and when the patient was being transported and in the elevator, the staff noticed blood in the second catheter.Intra-aortic balloon in the second catheter.Intra-aortic balloon pump (iabp) therapy was interrupted / delayed and was reported to have caused harm to the patient.Medical / surgical intervention was required and noted as ecmo (extracorporeal membrane oxygenation) to save the patient.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 8 FR - 40 CC FOS
• Type of Device: INTRA-AORTIC BALLOON FIBEROPTIC SYSTEM
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4553389
• MDR Text Key: 5455459
• Report Number: 1219856-2015-00042
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F14H0060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 67