MAUDE Adverse Event Report: ARROW INTERVENTIONAL, INC. (SUBSIDIARY OF ARROW INTL, INC) FIBEROPTIX; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IAB-05840-LWS

Device Problem Aspiration Issue (2883)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2015

Event Type  malfunction  

Event Description

Physician was placing an iab in the right femoral artery and when he tried to aspirate the balloon after placement it would not pull back.A new balloon was used to complete the procedure manufacturer response for 40cc fiberoptix iab 8fr, arrow fiberoptix (per site reporter): manufacturer provided rga# and shipping container for return evaluation.

• Brand Name: FIBEROPTIX
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERVENTIONAL, INC. (SUBSIDIARY OF ARROW INTL, INC); 9 plymouth street; everett MA 02149
• MDR Report Key: 5180069
• MDR Text Key: 29322662
• Report Number: 5180069
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2015

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: Physician
• Device Expiration Date: 08/01/2016
• Device Model Number: IAB-05840-LWS
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F14H0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 121