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

Model Number 0684-00-0480-01

Device Problems Off-Label Use (1494); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Event site postal code: (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id #: (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the iab was attached the patient's chest leaving a "c"-shaped loop in the iab which bends and kinks and blocks a lot of patient movement.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This is the fourth iab the customer has had this issue with during this event.There was no patient harm or adverse event reported.This report is for the third iab used in this event.Separate reports will be sent for the first, second, and fourth iabs used.

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 device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall 24 month product complaint trend data for the period (b)(6) through (b)(6) was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).H3 other text: device not returned.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the iab was attached the patient's chest leaving a "c"-shaped loop in the iab which bends and kinks and blocks a lot of patient movement.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This is the fourth iab the customer has had this issue with during this event.There was no patient harm or adverse event reported.This report is for the third iab used in this event.Separate reports will be sent for the first, second, and fourth iabs used.

• 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: 11366630
• MDR Text Key: 233102675
• Report Number: 2248146-2021-00119
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: 10607567106564
• 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: 06/23/2021

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 Model Number: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1