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 Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

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 # (b)(4).

Event Description

It was reported that after a percutaneous coronary intervention (pci) using an intra-aortic balloon (iab) the patient was transferred to the intensive care unit (icu).The male luer connection for the iab was found to be disconnected and blood was leaking from the site.Another tubing was used to connect the iab to the intra-aortic balloon pump (iabp) and therapy continued.There was no reported patient injury.

Event Description

It was reported that after a percutaneous coronary intervention (pci) using an intra-aortic balloon (iab) the patient was transferred to the intensive care unit (icu).The male luer connection for the iab was found to be disconnected and blood was leaking from the site.Another tubing was used to connect the iab to the intra-aortic balloon pump (iabp) and therapy continued.There was no reported patient injury.

Manufacturer Narrative

The pressure tubing was returned with traces of blood at the male and female ports.The pressure tubing male port was found detached from the rest of the pressure tubing assembly.No further damage noted.A measurement of the tubing diameter was performed and was found to be within specifications.Under magnification, there was what appeared to be adhesive residue visible on the tubing assembly.The supplier quality department was informed, whom in turn contacted the supplier icu medical about the issue.Pictures of the tubing were provided to the supplier.Icu medical conducted an investigation and found that no nonconformances were associated to the tubing lot # 4346712.However, the supplier confirmed that there were irregularities in their tubing assembly process.There were no ncmrs or scars in the past for the reported problem.Based on the returned condition of the device, the evaluation confirmed the reported problem.The root cause is related the supplier during their tubing assembly and curing process.The issue is currently being addressed by the supplier.A 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).

Event Description

It was reported that after a percutaneous coronary intervention (pci) using an intra-aortic balloon (iab) the patient was transferred to the intensive care unit (icu).The male luer connection for the iab was found to be disconnected and blood was leaking from the site.Another tubing was used to connect the iab to the intra-aortic balloon pump (iabp) and therapy continued.There was no reported patient injury.

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.Reference complaint (b)(4) h3 other text : device not returned.

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 that after a percutaneous coronary intervention (pci) using an intra-aortic balloon (iab) the patient was transferred to the intensive care unit (icu).The male luer connection for the iab was found to be disconnected and blood was leaking from the site.Another tubing was used to connect the iab to the intra-aortic balloon pump (iabp) and therapy continued.There was no reported patient injury.

• 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: 10293837
• MDR Text Key: 200274336
• Report Number: 2248146-2020-00360
• 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,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2020
• 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: 08/04/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1