MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0292

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the balloon had ruptured.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the balloon had ruptured.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and traces of blood found on the exterior of the catheter.Moderate blood was observed in the membrane and catheter.No kinks were observed on the catheter.The product was returned with only the membrane, catheter, y-fitting and statguard.No other defects were observed.A laboratory extracorporeal tube was used for the leak test.An underwater leak test of the balloon, catheter, y-fitting, and laboratory extracorporeal tubing was performed and one leak was detected on the membrane approximately 1.78cm from the rear seal measuring 0.015cm in length.The technician used a laboratory 0.025" guidewire to go through the inner lumen of the returned iab and found that the inner lumen had traces of blood but was cleared.The inner lumen leak test was performed and passed with no leaks.The reported problem was most likely triggered by the leak found on the membrane.The penetration found on the membrane appears to have been caused by a sharp object.We are unable to determine when this may have occurred.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint record # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the balloon had ruptured.There was no reported injury to the patient.

Manufacturer Narrative

Updated sections: date of report, concomitant medical products, premarket identification, type of report, follow up type, device evaluated by mfr, adverse event problem, additional mfr narrative.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided, we will send a supplemental report with our additional findings.Complaint record # (b)(4).

• Brand Name: MEGA 7.5FR. 30CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9520171
• MDR Text Key: 189092749
• Report Number: 2248146-2019-00947
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K120868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2022
• Device Catalogue Number: 0684-00-0292
• Device Lot Number: 3000097973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1