MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0475

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.One kink was found on the inner lumen/catheter tubing near the y-fitting approximately 76.5cm from the iab tip.The technician attempted to flush/aspirate the inner lumen and was unable to do so.The technician then attempted to insert a 0.025¿ laboratory guide wire through the inner lumen and resistance was only felt at the kinked location.The condition of the iab as received indicated a kink on the inner lumen/catheter tubing.This can cause the reported problems.A device and lot history record review and trend evaluation was completed for the reported product.No nonconformances were found that are considered to be related to the event.

Event Description

The hospital reported dr.(b)(6) called the esp hotline to report that the inner lumen of the catheter clotted and they were not able to obtain an arterial pressure.He requested to send the balloon back for evaluation to determine what could have made the central lumen clot so quickly after insertion).Iab was removed and a replacement iab was inserted to continue iabp therapy.

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 5261982
• MDR Text Key: 32563155
• Report Number: 2248146-2015-01043
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K08059223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2015

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/14/2018
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000009605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR