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

Catalog Number 0684-00-0605

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

Event site postal code: (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 became unwrapped, and could no longer be used.The iab was removed, and a therapy was successfully completed using a new iab.There was no patient harm, or adverse event reported.

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.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint (b)(4).H3 other text : device not returned.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the iab became unwrapped and could no longer be used.The iab was removed and a therapy was successfully completed using a new iab.There was no patient harm or adverse event reported.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the iab became unwrapped and could no longer be used.The iab was removed and a therapy was successfully completed using a new iab.There was no patient harm or adverse event reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter with the one-way valve attached.The sheath and insertion components were also returned.The guide wire was returned inside the iab lumen.The guide wire was removed and found to be bent in three places near the distal end and j-tip.The catheter tubing was observed to be oval shaped along its length.This may occur if a vacuum is held with the one-way valve attached for a long period of time on the catheter causing the catheter tubing to lose its round shape.The one-way valve was vacuum tested and it held vacuum.The sheath was measured and found to be within specification.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.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint # (b)(4).

• Brand Name: TRANS-RAY PLUS 7.5 FR. 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: 10885345
• MDR Text Key: 217722952
• Report Number: 2248146-2020-00626
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000115980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 12/30/2020; 01/08/2021
• Supplement Dates FDA Received: 12/30/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1