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

Catalog Number 0684-00-0475

Device Problems Air Leak (1008); Material Rupture (1546)

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

Event Date 01/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The iab balloon catheter has been returned however at this time it has not been evaluated by a datascope service representative.When the evaluation for the iab balloon catheter is completed or if any additional information becomes available a follow up med watch will be submitted.A review of the complaint trends does not indicate any manufacturing or systemic issues (b)(4).The iab balloon catheter has been returned how att his time it has not been evaluated by a datascope service representative.When the evaluation for the iab balloon catheter is completed or if any additional information becomes available a follow up med watch will be submitted.A review of the complaint trends does not indicate any manufacturing or systemic issues.

Event Description

Nurse practitioner called esp line to report that iab was removed from patient at 5pm earlier that day due to a "rupture" in the balloon.Blood was observed in the balloon membrane and in the helium tubing.Balloon was removed at that time.Patient remained stable throughout.The esp call came at 11pm sunday (b)(6).Np reports that on a ct scan of abdomen, "several large pockets of air" are visible in the aorta and that it is assumed from the leak of the iab catheter.

Manufacturer Narrative

(b)(4).The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter but it was not a datascope product.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 1.8cm from the rear seal measuring 0.025cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.Complaint #: (b)(4); record id: (b)(6).Supplemental # 1.

Event Description

Nurse practitioner called esp line to report that iab was removed from patient at 5pm earlier that day due to a "rupture" in the balloon.Blood was observed in the balloon membrane and in the helium tubing.Balloon was removed at that time.Patient remained stable throughout.The esp call came at 11pm sunday (b)(6).Np reports that on a ct scan of abdomen, "several large pockets of air" are visible in the aorta and that it is assumed from the leak of the iab catheter.

• 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: 5455140
• MDR Text Key: 39262391
• Report Number: 2248146-2016-00014
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2018
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000018278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 02/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• 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: 63 YR