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

Model Number 0684-00-0480-01C

Device Problems Filling Problem (1233); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported during intra-aortic balloon(iab) therapy, the console generated an autofill failure alarm.The catheter was checked and the catheter extender was damaged.There was no reported injury to the patient.

Event Description

It was reported during intra-aortic balloon(iab) therapy, the console generated an autofill failure alarm.The catheter was checked and the catheter extender was damaged.There was no reported injury to the patient.

Manufacturer Narrative

Additional information return to manufacture date, device evaluated by mfg, device not eval provide code, evaluation result codes, evaluation conclusion codes.The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint (b)(4).

Manufacturer Narrative

The product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter.The extender tubing was also returned.Additionally, a catheter tubing kink and a flattened/deformed section were also observed at approximately 76.5cm & 34.5cm from the iab tip respectively.An underwater leak test of the balloon, catheter tubing, y-fitting, extracorporeal tubing and extender tubing was performed and a leak was detected on the extender tubing at approximately 3.3cm from the female port and measuring 1.5cm in length.The evaluation confirmed the reported extender tubing damage, which appeared to had been caused by a sharp object.However, we are unable to determine when this may have occurred.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.Reference complaint #(b)(4).

Event Description

It was reported during intra-aortic balloon(iab) therapy, the console generated an autofill failure alarm.The catheter was checked and the catheter extender was damaged.There was no reported injury to the patient.

• Brand Name: LINEAR 7.5 FR. 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: 10457366
• MDR Text Key: 219524104
• Report Number: 2248146-2020-00436
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109343
• UDI-Public: 10607567109343
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2020

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: 09/24/2022
• Device Model Number: 0684-00-0480-01C
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000104997
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 10/12/2020
• Supplement Dates FDA Received: 09/18/2020; 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 65