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

Model Number 0684-00-0480-07

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Event site postal code: (b)(4).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 after inserting the intra-aortic balloon (iab), it had ruptured.The customer replaced the iab with a new one.However, the second iab ruptured as well and was replaced with a third iab.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report for the second iab used has been submitted under mfg report number 2248146-2021-00111.

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 after inserting the intra-aortic balloon (iab), it had ruptured.The customer replaced the iab with a new one.However, the second iab ruptured as well and was replaced with a third iab.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report for the second iab used has been submitted under mfg report number 2248146-2021-00111.

• Brand Name: LINEAR 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: 11365992
• MDR Text Key: 244264551
• Report Number: 2248146-2021-00112
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109718
• UDI-Public: 10607567109718
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2022
• Device Model Number: 0684-00-0480-07
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000108623
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 70