MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0568-01

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2020

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 with blood on the exterior, interior, between the catheter, and the returned maquet sheath.A catheter tubing kink was observed at approximately 34.5cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing, and extender tubing was performed, and a leak was detected on the membrane at approximately 1.3cm from the rear seal and measuring approximately 0.013cm in length.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.The failure mode is addressed in the risk file, and is operating within its risk profile.The ifu addresses the as analyzed 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

It was reported that during the investigation of the device involved in mfg report number 2248146-2020-00510 a kink was found that was unrelated to the reported leak failure mode.There was no patient involvement.

• Brand Name: SENSATION 7FR. 40CC 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: 10722507
• MDR Text Key: 212987241
• Report Number: 2248146-2020-00556
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000110834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2019
• 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