MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 34CC IAB (CHINA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after approximately 45 hours of intra-aortic balloon (iab) therapy, the pump generated a frequent alarm.Blood was seen in the tubing.The iab was then removed.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Complete event site name:(b)(6) hospital.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).
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded with traces of blood on the exterior and interior of the membrane.The sheath was returned over the catheter tubing and part of the membrane.A visual examination of the product detected the inner lumen within the membrane was completely separated approximately 2.3cm from iab tip.One kink was observed within the catheter tubing approximately 76.2cm from the iab tip.The pressure tubing was also returned.The male lure was returned stretched or oversized.The iab membrane was found to be aneurized when inflated with air.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and pressure tubing was performed, and no other leaks were detected.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing causing the reported problems.It is difficult to determine when the lumen break occurred, but it is possibly a result of patient movement during the procedure.The evaluation confirmed the reported problem.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).
Additional Manufacturer Narrative
Complaint record id #(b)(4).

• Brand Name: LINEAR 7.5FR. 34CC IAB (CHINA)
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 17942335
• Report Number: 2248146-2023-00618
• Device Sequence Number: 2983479
• Product Code: DSP
• UDI-Device Identifier: 10607567109343
• UDI-Public: (01)10607567109343(10)3000300846(17)260228(11)230301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2024

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: 02/28/2026
• Device Model Number: 0684-00-0479-01C
• Device Catalogue Number: 0684-00-0479-01C
• Device Lot Number: 3000300846
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 11/14/2023; 09/06/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/14/2023; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 66 KG