MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 34CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01U
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: (b)(6).Additional reporter: sara matter, mba, rn, clinical value analyst, matter.Sara@mayo.Edu, (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 or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, a gas loss alarm was generated and an "iab rupture" occurred.The insertion was reported to be axillary, which is not the method described in the device instructions for use.Iab was removed and no other concerns noted.The iab was in use for approximately two days.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Updated field(s): describe event or problem, serial#, initial reporter, event site email.Device evaluation: the iab was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering the rear portion of the balloon.The one-way valve was returned attached to the iab.A kink was found on the catheter tubing and inner lumen approximately 76.5cm from iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was observed on the catheter tubing at the kinked location of 76.5cm.The penetration found in the catheter tubing appears to have been caused by a kink flexing back and forth that eventually penetrated the tubing causing the reported problems.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the iab failure.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).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, a gas loss alarm was generated and an "iab rupture" occurred.The insertion was reported to be axillary, which is not the method described in the device instructions for use.Iab was removed and no other concerns noted.The iab was in use for approximately 43 hours.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Udi related data quality updates only: providing updated device identification information in alignment with gudid.Complaint record id # (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 34CC IAB WITH ACCESSORIES, US ONLY
• 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: jingal amin ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 19659240
• Report Number: 2248146-2024-00406
• Device Sequence Number: 6624532
• Product Code: DSP
• UDI-Device Identifier: 10607567109503
• UDI-Public: (01)10607567109503(10)3000289564(17)260109(11)230110
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2024

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: 01/09/2026
• Device Model Number: 0684-00-0479-01U
• Device Catalogue Number: 0684-00-0479-01U
• Device Lot Number: 3000289564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 11/20/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/11/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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 Sex: Unknown