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

Model Number 0684-00-0576-01U

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Evaluation: the product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter.Two 0.025¿ guidewires were also returned, one of which was undamaged.The damaged guidewire was bent and unraveled at approximately 87.1cm and 15.2cm from the j-tip respectively.Additionally, a flat/deformed section on the catheter tubing was also observed at approximately 29.7cm from the iab tip.The evaluation confirms the presence of a flat/ deformed section on the catheter tubing as an as analyzed failure.However, we are unable to conclusively determine when this may have occurred.Therefore, the root cause for the flat/ deformed section is impossible to define.A device and lot history record review was completed for the reported product.No nonconformance's were found that are considered to be related to the event.Reference complaint #: (b)(4).

Event Description

It was reported that during the investigation of the device involved in complaint number (b)(4) a flat/ deformed catheter tubing was found that was unrelated to the reported difficult/ unable to remove guidewire failure mode.There was no patient involvement.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: dorota wolpiuk ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 10627032
• MDR Text Key: 209801509
• Report Number: 2248146-2020-00523
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• UDI-Public: 10607567109633
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: 0684-00-0576-01U
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000116330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1