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

Model Number	0684-00-0480-10
Medical Device Problem Codes	Device Alarm System (1012); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when intra-aortic balloon (iab) therapy was about to be initiated, the console generated an alarm and blood was seen in the iab.When the iab was checked, a small hole was noticed at the tip.A new iab was inserted to continue therapy.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Occupation: perfusionist.Event site postal code: (b)(6).Additional email: (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).
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and blood in the inner lumen.Two kinks were observed on the catheter approximately 76.4cm and 74.4cm from the iab tip.The extender tubing and pressure tubing were also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, pressure tubing and extender tubing was performed and a leak was detected on the membrane approximately 23.1cm from the rear seal and measuring 0.051cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.The penetration found on the membrane appears to have been caused by a sharp object.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint # (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 17152216
• Report Number: 2248146-2023-00397
• Device Sequence Number: 20338697
• Product Code: DSP
• UDI-Device Identifier: 10607567113159
• UDI-Public: 10607567113159
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2023
• Device Model Number: 0684-00-0480-10
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000129061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG