MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-01
Medical Device Problem Codes	Pacing Problem (1439); Device Sensing Problem (2917); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User called into emergency support program line to request support with an unable to update timing alarm and unable to calibrate intra-aortic balloon (iab) optical sensor messages.(b)(6), an icu rn, stated that ap numbers have been inconsistent for a few days.A screenshot of the iabp monitor revealed an arterial waveform with significant artifact using the fo sensor as the ap source.Esp personnel recommended (b)(6) to place the pump on standby and flush the inner lumen for 20-30 seconds.She followed the instructions; however, this did not resolve the artifact.Esp personnel recommended (b)(6) switch to the inner lumen as the ap source.(b)(6) switched to the inner lumen and zeroed without difficulty.A screenshot of the iabp monitor revealed an appropriate waveform, however suboptimal augmentation was noted.Esp personnel recommended a chest xray to ensure the distal marker was located in between the second and third intercostal space.Esp personnel also requested (b)(6) place the pump in 1:2 to check timing.Esp personnel brought the native arterial waveform to (b)(6) attention as it was very difficult to see a dicrotic notch that would allow us to verify appropriate timing.(b)(6) was unsure if the patient was diagnosed with aortic insufficiency.She also stated she felt it was not in their scope to adjust timing, if needed.(b)(6) placed the pump back into 1:1 frequency.She stated she would discuss with the physician or app.A few minutes later, (b)(6) followed up and sent a chest xray which revealed the distal marker in between the second and third intercostal space.She had no other questions.(b)(6) the dayshift rn, followed up with a picture of the iabp monitor.(b)(6) was requesting assistance to verify timing.Esp personnel provided a screenshot of the iabp monitor in 1:2 frequency.Esp brought to (b)(6) attention the dicrotic notch was difficult to assess and the importance of a dicrotic notch when verifying timing.(b)(6) placed the pump back into 1:1 frequency.She stated she would discuss with the physician and call back if she have any additional questions.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Other contact 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).
Additional Manufacturer Narrative
Updated fields b4 g3 g6 h2 h3 h6 type of investigation investigation findings component code investigation conclusions h11.Additional initial reporter is katie.User called into emergency support program line to request support with an unable to update timing alarm and unable to calibrate intra aortic balloon iab optical sensor messages icu rn stated that ap numbers have been inconsistent for a few days a screenshot of the iabp monitor revealed an arterial waveform with significant artifact using the fo sensor as the ap source esp personnel recommended nurse to place the pump on standby and flush the inner lumen for 2030 seconds she followed the instructions however this did not resolve the artifact esp personnel recommended nurse switch to the inner lumen as the ap source nurse switched to the inner lumen and zeroed without difficulty a screenshot of the iabp monitor revealed an appropriate waveform however suboptimal augmentation was noted esp personnel recommended a chest xray to ensure the distal marker was located in between the second and third intercostal space esp personnel also requested nurse place the pump in 12 to check timing esp personnel brought the native arterial waveform to nurse attention as it was very difficult to see a dicrotic notch that would allow us to verify appropriate timing nurse was unsure if the patient was diagnosed with aortic insufficiency she also stated she felt it was not in their scope to adjust timing if needed nurse placed the pump back into 11 frequency she stated she would discuss with the physician or app a few minutes later nurse followed up and sent a chest xray which revealed the distal marker in between the second and third intercostal space she had no other questions nurse the day shift rn followed up with a picture of the iabp monitor katie was requesting assistance to verify timing esp personnel provided a screenshot of the iabp monitor in 12 frequency esp brought to nurse attention the dicrotic notch was difficult to assess and the importance of a dicrotic notch when verifying timing katie placed the pump back into 11 frequency she stated she would discuss with the physician and call back if she have any additional questions there was no patient harm or injury reported.
Event or Problem Description
N/a.

• Brand Name: SENSATION 7FR. 40CC IAB
• 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: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 23992958
• Report Number: 2248146-2026-0000120
• Device Sequence Number: 10509631
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000487060(17)280701(11)250701
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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 Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3000487060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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: CS300
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 81 KG