MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

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 insertion of the intra-aortic balloon (iab), the guide wire could not be advanced through the inner lumen of the balloon.There was also difficulty removing the guide wire.There was no reported injury to the patient.

Manufacturer Narrative

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).

Event Description

It was reported during insertion of the intra-aortic balloon (iab), the guide wire could not be advanced through the inner lumen of the balloon.There was also difficulty removing the guide wire.There was no reported injury to the patient.

Manufacturer Narrative

Updated sections: b4, g4, g7, h2, h3, h6, h10.The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter.The returned 0.025¿ guide wire was found partially inside the iab lumen.The returned guide wire was able to be removed from the iab lumen without difficulty.A small part of the wire was unraveled approximately 1/4¿in length.A laboratory guide wire was used.One kink was found on the catheter tubing near the y-fitting approximately 75.4cm from the iab tip.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.The reported event cannot be confirmed by the evaluation.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.Complaint # (b)(4).

Event Description

It was reported during insertion of the intra-aortic balloon (iab), the guide wire could not be advanced through the inner lumen of the balloon.There was also difficulty removing the guide wire.There was no reported injury to the patient.

• Brand Name: LINEAR 7.5 FR. 34CC 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: 9398213
• MDR Text Key: 194838710
• Report Number: 2248146-2019-00903
• Device Sequence Number: 1
• Product Code: DSP
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2022
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000090433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 56