MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0498-01

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint # (b)(4).

Event Description

It was reported that after opening the insert kit, the customer found the guidewire was damaged.The customer changed to another guidewire.There was no reported injury to the patient.

Manufacturer Narrative

Two guidewires were returned along with insertion components and extender tubing.The reported 0.025¿ guidewire was returned inside the protective tubing and appeared to have been used.Both the guidewire and the protective tubing had traces of blood.One guidewire was also observed to be unraveled at approximately 5.1cm from the j-tip.No other damage observed.The evaluation confirmed the reported problem.However, we are unable to conclusively determine how the guidewire became unraveled since we are unable to duplicate the clinical settings.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint (b)(4).

Event Description

It was reported that after opening the insert kit, the customer found the guidewire was damaged.The customer changed to another guidewire.There was no reported injury to the patient.

• Brand Name: MEGA 8FR. 50CC 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: 10465240
• MDR Text Key: 206564791
• Report Number: 2248146-2020-00440
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107301
• UDI-Public: 10607567107301
• Combination Product (y/n): N
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Model Number: 0684-00-0498-01
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000110167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 66