MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0434

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

Complete contact person 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 during intra-aortic balloon (iab) therapy, the iab could not be advanced by the introducer.The iab was removed and replaced with a new one.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the iab could not be advanced by the introducer.The iab was removed and replaced with a new one.There was no reported injury to the patient.

Manufacturer Narrative

Additional information: section h - evaluation method codes added: historical data analysis; 4109.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.Reference complaint # (b)(4).

Manufacturer Narrative

Section d - brand name.From: linear 7.5 fr.40cc.To: sensation 7fr.40cc iab.The product was returned with the membrane partially folded with traces of blood on the exterior of the catheter.The angiographic needle, dilator, 0.035¿ guidewire, 3-way stopcock and extender tubing were also returned.An inner lumen kink was observed inside the membrane at approximately 15cm from the iab tip.Additionally, a catheter tubing kink was also observed near the y-fitting at approximately 76cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and no leaks were detected.A laboratory insertion test was unable to be performed due to the returned condition of the iab.Kinks can cause difficulty advancing the iab through the sheath.However, the evaluation was unable to confirm the reported problem due to the returned condition of the iab.We are unable to duplicate the clinical settings.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 that during intra-aortic balloon (iab) therapy, the iab could not be advanced by the introducer.The iab was removed and replaced with a new one.There was no reported injury to the patient.

• Brand Name: SENSATION 7FR. 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: 9866716
• MDR Text Key: 185523113
• Report Number: 2248146-2020-00168
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2022
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000100339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR