MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0605

Device Problems Difficult to Insert (1316); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2020

Event Type  malfunction  

Manufacturer Narrative

Event site postal code - (b)(4).Complete event site name - (b)(4) medical center.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 wrapping was unraveled before the balloon membrane passed through the sheath, and it did not pass through the hub of the sheath.Another iab was used to start therapy.There was no reported injury to the patient.

Event Description

It was reported during insertion of the intra-aortic balloon (iab), the wrapping was unraveled before the balloon membrane passed through the sheath, and it did not pass through the hub of the sheath.Another iab was used to start therapy.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.Reference complaint #: (b)(4).

Event Description

It was reported during insertion of the intra-aortic balloon (iab), the wrapping was unraveled before the balloon membrane passed through the sheath, and it did not pass through the hub of the sheath.Another iab was used to start therapy.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The sheath was not returned for evaluation.The inner lumen was found to be occluded with dried blood.The occlusion was able to be cleared.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 of the returned condition of the catheter and we are unable to mimic the clinical setting.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).

• Brand Name: TRANS-RAY PLUS 7.5 FR. 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9897812
• MDR Text Key: 185521252
• Report Number: 2248146-2020-00178
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2022
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000104728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 78