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

Catalog Number 0684-00-0605

Device Problems Inflation Problem (1310); Difficult to Insert (1316); Material Deformation (2976)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Event site postal code: (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 during insertion of the intra-aortic balloon (iab), when the guide wire was removed from the catheter, the catheter was unable to follow the meandering vessel and was kinked.The blood vessel meandering was severe and difficult.The iab was replaced to start therapy.There was no reported injury or adverse event to the patient.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.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 (b)(6) through (b)(6) was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).H3 other text: device not returned.

Event Description

N/a.

Manufacturer Narrative

Additional information changed describe event or problem, added medical device ¿ problem code 1310, device available for eval from yes to no.Reference complaint # (b)(4).

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), when the guide wire was removed from the catheter, the catheter was unable to follow the meandering vessel and was kinked and the iab would not inflate.The blood vessel meandering was severe and difficult.The iab was replaced to start therapy without any further issues.There was no reported injury or adverse event to the patient.

• Brand Name: TRANS-RAY PLUS 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
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 12101434
• MDR Text Key: 259596751
• Report Number: 2248146-2021-00422
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2023
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000121673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1