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

(b)(6).The product was returned with the membrane completely unfolded with blood on the exterior of the catheter.The extender tubing was also returned.An inner lumen kink was observed inside the membrane at approximately 6.3cm from the iab tip.A flattened/deformed section on the catheter tubing was also observed from approximately 29.7cm through 45.5cm measured from the iab tip.Lastly, a catheter tubing/inner lumen/optical fiber break was observed at approximately 76.2cm from the iab tip.The evaluation confirms the presence of a kink, flat catheter tubing and broken fiber as ¿as analyzed¿ failures.However, we are unable to conclusively determine when these may have occurred.Therefore, the root cause 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.The device meets all product specifications (this sentence goes away if the complaint if confirmed).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 2248146-2020-00554, a kink was found that was unrelated to the reported leak failure mode.There was no patient involvement.

Manufacturer Narrative

Correction made to section g - report source.Changed to just company representative.Reference complaint # (b)(4).

Event Description

During the investigation of the returned intra-aortic balloon (iab) involved under mfg report number 2248146-2020-00554, 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
• MDR Report Key: 11214512
• MDR Text Key: 230758642
• Report Number: 2248146-2021-00038
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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: 12/18/2021
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000086897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1