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

Model Number	0684-00-0480-01C
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1 full event site name, address, and phone number: (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 or Problem Description
It was reported by the customer that during intra-aortic balloon (iab) therapy, the balloon could not inflate after inserting the iab catheter and changed a new one.There was no patient harm.
Additional Manufacturer Narrative
Updated fields: b4, d9 (return to manufacture date), g1 (contact person ¿ mfg site) g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: d8.The product was returned with the membrane completely unfolded and blood was observed on the exterior and between iab and sheath.The 7.5fr sheath was returned covering the catheter tubing.One kink was observed on the catheter tubing approximately 73.1cm from the iab tip.The three-way stopcock was also returned.- an underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed, and a catheter penetration was observed on the catheter tubing approximately 68.6cm from the iab tip.The evaluation determined a catheter tubing penetration, confirming the failure reported.It is difficult to determine when or how this occurred.The leak size suggests that a sharp object may have caused it, no marks were found around the leak.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint id no.: (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 40CC IAB (CHINA)
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21121870
• Report Number: 2248146-2025-0000017
• Device Sequence Number: 8760467
• Product Code: DSP
• UDI-Device Identifier: 10607567109343
• UDI-Public: (01)10607567109343(10)3000356065(17)270119(11)240119
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0480-01C
• Device Catalogue Number: 0684-00-0480-01C
• Device Lot Number: 3000356065
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 60 KG