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

Catalog Number 0684-00-0575

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2019

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that a patient required intra-aortic balloon pump (iabp) therapy for support post-operatively.The surgeon was unable to insert the intra-aortic balloon (iab) in theatre due to poor peripheral access and so patient went to the intensive therapy unit with no support.It was reported that the surgeon went through 2 introducer kits because the guidewires and dilators kept kinking.It was decided by the intensivist later on in the night that the patient required circulatory support, and so he attempted to insert a 50cc fiber optic iab catheter.This was successful, but was reported to be difficult to do.It was necessary to use a sheath to maintain patency of the vessel as the patient had a very large abdomen.Patient subsequently went back to theatre for extracorporeal membrane oxygenation (ecmo) support; by this point the leg on the balloon side was white.It was reported that the surgeon then had difficulty removing the balloon and he expected it to be able to pass through the sheath.The surgeon indicated the event was traumatic for the patient and that the patient had to have vascular repair.It was reported that the insertion kits were both disposed of upon completion and the lot information was not retained.This report is for the iab kit that was able to be inserted and used.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering the rear portion of the balloon.The guide wire and dilator were not returned for evaluation.One kink was found on the inner lumen within the membrane approximately 19.6cm from the iab tip.The returned sheath tubing was found to be accordioned along its length.A laboratory insertion test was unable to be performed due to the membrane being unfurled, the sheath returned in place over the catheter tubing and the 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 inner lumen.A kink in the inner lumen can cause difficulty during insertion.We are unable to determine when the kink may have occurred.We were unable to mimic the clinical setting for difficult to remove iab from the patient.We were unable to confirm any damage to the guide wire and dilator because they were not returned.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); record id (b)(4).

Event Description

It was reported that a patient required intra-aortic balloon pump (iabp) therapy for support post-operatively.The surgeon was unable to insert the intra-aortic balloon (iab) in theatre due to poor peripheral access and so patient went to the intensive therapy unit with no support.It was reported that the surgeon went through 2 introducer kits because the guidewires and dilators kept kinking.It was decided by the intensivist later on in the night that the patient required circulatory support, and so he attempted to insert a 50cc fiber optic iab catheter.This was successful, but was reported to be difficult to do.It was necessary to use a sheath to maintain patency of the vessel as the patient had a very large abdomen.Patient subsequently went back to theatre for extracorporeal membrane oxygenation (ecmo) support; by this point the leg on the balloon side was white.It was reported that the surgeon then had difficulty removing the balloon and he expected it to be able to pass through the sheath.The surgeon indicated the event was traumatic for the patient and that the patient had to have vascular repair.It was reported that the insertion kits were both disposed of upon completion and the lot information was not retained.This report is for the iab kit that was able to be inserted and used.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8384022
• MDR Text Key: 138133630
• Report Number: 2248146-2019-00148
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000079460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Device Age: YR
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 105