MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0568-01

Device Problems Material Deformation (2976); Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

The initial reporter was a getinge employee.Initial reporter name: (b)(6).The product was returned with the membrane completely unfolded, and blood on the exterior of the catheter.No blood was observed inside the iab catheter.A kink was observed within the membrane on the inner lumen approximately 9.4cm from the iab tip.The optical fiber was also found to be broken at the kinked location.The inner lumen was found to be occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed, and no leaks were detected.The evaluation confirms the presence of a kink and optical fiber break 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 nonconformances were found that are considered to be related to the event.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, 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

It was reported that during the investigation of the device involved in mfg report number 2248146-2020-00546 a kink and optical fiber break was found that was unrelated to the reported leak failure mode.There was no patient involvement.

Event Description

It was reported that during the investigation of the device involved in mfg report number 2248146-2020-00546 a kink and optical fiber break was found that was unrelated to the reported leak failure mode.There was no patient involvement.

Manufacturer Narrative

Correction section g report source changed health professional, user facility, company representative to company representative.

• Brand Name: SENSATION PLUS 7.5FR. 40CC 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: 10779269
• MDR Text Key: 214812040
• Report Number: 2248146-2020-00580
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: 10607567108063
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

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: 03/10/2023
• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000116944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1