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

Catalog Number 0684-00-0575

Device Problems Mechanical Problem (1384); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

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 during intra-aortic balloon (iab) insertion, the sheath ¿crimped¿ at the insertion site. The sheath was removed and a competitor's sheath was used. However, the iab would not advance through the competitor's sheath either. A new iab was used and was able to be inserted through the competitor's sheath. The indication for use was stemi (st-elevation myocardial infarction) with cardiogenic shock. There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter. The sheath was not returned for evaluation. One kink was found on the catheter tubing near the y-fitting approximately 76. 2cm from the iab tip. A laboratory insertion test was unable to be performed due to the membrane being unfurled. 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. We are unable to confirm the reported difficulty during insertion because the sheath was not returned, the returned condition of the catheter, and we are unable to mimic the clinical setting. An evaluation of the product was unable to duplicate the reported problem. The product performed according to specification. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) insertion, the sheath ¿crimped¿ at the insertion site. The sheath was removed and a competitor's sheath was used. However, the iab would not advance through the competitor's sheath either. A new iab was used and was able to be inserted through the competitor's sheath. The indication for use was stemi(st-elevation myocardial infarction) with cardiogenic shock. There was no reported injury to the patient.

• 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
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7662361
• MDR Text Key: 113305451
• Report Number: 2248146-2018-00428
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/19/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000067897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage