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

Model Number 0684-00-0295-05

Device Problems Difficult to Insert (1316); Defective Component (2292); Defective Device (2588)

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

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Complete event site name:(b)(6).Complete event site address: (b)(6).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 after removing the intra-aortic balloon (iab) from the packaging, the customer noticed the tip of the iab was broken and could not be inserted.There was no patient harm or adverse event reported.

Manufacturer Narrative

Corrected information: section h changed medical device ¿ problem code 2292 to 2588 device evaluation: the iab was returned with the membrane completely unfolded with the one-way valve attached.No blood was visible on the catheter.The sheath was not returned for evaluation.The catheter tubing was observed to be flattened 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.No damage was observed on the iab tip.The one-way valve was vacuum tested and it held vacuum.A laboratory insertion test was unable to be performed due to the membrane being unfurled and the catheter tubing returned condition.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).

Event Description

It was reported that after removing the intra-aortic balloon (iab) from the packaging, the customer noticed the tip of the iab was broken and could not be inserted.There was no patient harm or adverse event reported.

• Brand Name: MEGA 7.5FR. 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: 11366154
• MDR Text Key: 233103607
• Report Number: 2248146-2021-00115
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109039
• UDI-Public: 10607567109039
• Combination Product (y/n): N
• PMA/PMN Number: K120868
• 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: 05/11/2021

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: 06/01/2023
• Device Model Number: 0684-00-0295-05
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000122734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 80