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 Defective Component (2292)

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

Event Date 01/11/2021

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 record id # (b)(4).

Event Description

It was reported that during insertion a defect was noticed near the tip of the intra-aortic balloon (iab).There was no patient harm or adverse event reported.

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).

Event Description

It was reported that during insertion a defect was noticed near the tip of the intra-aortic balloon (iab).There was no patient harm or adverse event reported.

Event Description

N/a.

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id #: (b)(4).

Manufacturer Narrative

Additional information: changed serial number to: (b)(6).Device evaluation: the product was returned with the membrane completely unfolded with trace amounts of blood in the balloon.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was detected on the membrane seal approximately 28.96cm from the iab tip and measuring approximately 0.076cm in length.The reported problem was most likely triggered by the leak found on the membrane rear seal.The evaluation confirms the reported problem.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period nov-19 through jan-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.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 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 11293209
• MDR Text Key: 230716902
• Report Number: 2248146-2021-00067
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109718
• UDI-Public: 10607567109718
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 04/01/2021; 06/30/2021; 11/19/2021
• Supplement Dates FDA Received: 04/01/2021; 07/20/2021; 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 68 KG