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

Model Number 0684-00-0576-01

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

The initial reporter is a getinge representative.Pedro ore / phone number: (b)(6).The product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter and between the catheter and the returned non-maquet sheath.The extender tubing was also returned.A catheter tubing kink was observed near the y-fitting at approximately 76.5cm from the iab tip.The evaluation confirms the presence of a catheter tubing 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.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint #: (b)(4).

Event Description

During the investigation of the returned intra-aortic balloon (iab) involved under mfg report number 2248146-2020-00659, a kink was found that was unrelated to the reported leak 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: 11215967
• MDR Text Key: 228481641
• Report Number: 2248146-2021-00039
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000121471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2020
• 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