MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANSRAY 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0513

Device Problem Break (1069)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that the guidewire provided in the intra-aortic balloon (iab) packaging had broken during insertion.A new one was used to successfully insert the iab.There was no patient harm or adverse event reported.

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).

Manufacturer Narrative

The 0.025¿ guide wire was returned inside the protective tubing without any visible blood.The j-tip of the returned guidewire was found to be unraveled.The iab was returned with the membrane completely unfolded.No blood was visible.The one-way valve and 0.035¿ guide wire were also returned.A kink was observed on the catheter tubing and inner lumen near the y-fitting approximately 76.5cm from iab tip.The evaluation confirms the reported problem.The unraveled j-tip of the guide wire may have occurred during removal from the packaging.However we are unable to conclusively determine how the damage occurred because we are unable to mimic the clinical setting.A 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

N/a.

• Brand Name: TRANSRAY 7FR. 34CC 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: 18741161
• MDR Text Key: 335936980
• Report Number: 2248146-2024-00096
• 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
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0513
• Device Lot Number: 3000300045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1