MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0567

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

The product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter.A competitor sheath and stat-gard sleeve were also returned separate from the iab.The catheter tubing, optical fiber and inner lumen were cut at approximately 63.5cm form the iab tip.The remaining portion of the iab was not returned.The stat-gard sleeve was cut at approximately 31.5cm from the stat-gard sleeve tip.An inner lumen break within a kink was observed within the membrane at approximately 23.6cm from the iab tip.Additionally, a catheter tubing kink and an optical fiber break were also observed at approximately 30.5cm from the iab tip.The evaluation confirms the presence of a kink as an as analyzed failure.However, we are unable to conclusively determine when this kink may have occurred.Therefore, the root cause for the kink 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.

Event Description

During the investigation of the returned intra-aortic balloon (iab) involved under mfg report number 2248146-2020-00305, a kink was found that was unrelated to the reported leak failure mode.There was no patient involvement.

• Brand Name: SENSATION PLUS 40CC
• 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: 10382535
• MDR Text Key: 202197996
• Report Number: 2248146-2020-00410
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• 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: 08/07/2020

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 Catalogue Number: 0684-00-0567
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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