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 Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  malfunction  

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.Complaint record id # (b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was bent out of the packaging.The customer tried to insert the iab but was unsuccessful.A new iab was opened and used without issue.There was no patient harm or adverse event reported.

Event Description

It was reported that the intra-aortic balloon (iab) was bent out of the packaging.The customer tried to insert the iab but was unsuccessful.A new iab was opened and used without issue.There was no patient harm or adverse event reported.

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded with blood on the exterior of the catheter.The extender tubing was also returned.An inner lumen kink was observed inside the membrane at approximately 3.3cm from the iab tip.The technician inserted a laboratory 0.025¿ guidewire through the inner lumen and obstruction was felt at the kink location.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and no leaks were detected.The condition of the iab as received indicated an inner lumen kink.It is difficult to determine when the kink occurred, however, kinks might cause iab insertion difficulty.The evaluation confirmed the reported problem.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: 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
• MDR Report Key: 11455613
• MDR Text Key: 243796066
• Report Number: 2248146-2021-00146
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000119428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 05/14/2021
• Patient Sequence Number: 1
• Patient Age: 55 YR