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

Model Number 0684-00-0498-01

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

Complete event site name: (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 that the intra-aortic balloon (iab) could not be inserted through the sheath.A new iab was inserted successfully to continue therapy.There was no patient harm or adverse event reported.

Manufacturer Narrative

The device has been returned to the factory, and is being evaluated.A supplemental report will be submitted, when the evaluation is completed.Complaint record id # (b)(4).

Event Description

N/a.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter with the one-way valve attached.The sheath was not returned for evaluation.A kink was found on the catheter tubing and inner lumen near the y-fitting approximately 75.9cm from the iab tip.The one-way valve was vacuum tested and it held vacuum a laboratory insertion test was unable to be performed due to the membrane being unfurled and the catheter tubing and inner lumen kinked.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The condition of the iab as received indicated a kink on the catheter tubing and inner lumen.A kink in the inner lumen can cause difficulty during insertion.We are unable to determine when the kink may have occurred.The evaluation confirmed the reported problem.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period nov-2019 to oct-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).

Event Description

N/a.

• Brand Name: MEGA 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 12852900
• MDR Text Key: 285633705
• Report Number: 2248146-2021-00780
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107301
• UDI-Public: 10607567107301
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2023
• Device Model Number: 0684-00-0498-01
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000132626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 75 KG