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

Model Number	0684-00-0480-02
Medical Device Problem Codes	Leak/Splash (1354); Pressure Problem (3012)
Health Effect - Clinical Codes	Emotional Changes (1831); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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).Device not returned.
Event or Problem Description
It was reported that during intra-aortic balloon(iab) therapy, the console alarmed high pressure alarm and shut off.Blood quickly filled helium tubing.Patients pressures dropped, became symptomatic, pale, anxious, dizzy.Cv code called.Cv code team threaded new iabp into axillary site, removed old iabp.Old iabp had broken wire and blood in helium tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.
Additional Manufacturer Narrative
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).H3 other text: device not returned.
Event or Problem Description
It was reported that during intra-aortic balloon(iab) therapy, the console alarmed high pressure alarm and shut off.Blood quickly filled helium tubing.Patients pressures dropped, became symptomatic, pale, anxious, dizzy.Cv code called.Cv code team threaded new iabp into axillary site, removed old iabp.Old iabp had broken wire and blood in helium tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.
Event or Problem Description
It was reported that during intra-aortic balloon(iab) therapy, the console alarmed high pressure alarm and shut off.Blood quickly filled helium tubing.Patients pressures dropped, became symptomatic, pale, anxious, dizzy.Cv code called.Cv code team threaded new iabp into axillary site, removed old iabp.Old iabp had broken wire and blood in helium tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.
Additional Manufacturer Narrative
Device available for eval? updated from yes to no.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.Reference complaint #: (b)(4).H3 other text : device not returned.
Event or Problem Description
It was reported that during intra-aortic balloon(iab) therapy, the console alarmed high pressure alarm and shut off.Blood quickly filled helium tubing.Patients pressures dropped, became symptomatic, pale, anxious, dizzy.Cv code called.Cv code team threaded new iabp into axillary site, removed old iabp.Old iabp had broken wire and blood in helium tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.
Additional Manufacturer Narrative
Additional initial reporter: randy green, cmrp assistant manager ¿ quality assurance.Additional email address: (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).

• 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
• MDR Report Key: 11578219
• Report Number: 2248146-2021-00193
• Device Sequence Number: 17049328
• Product Code: DSP
• UDI-Device Identifier: 10607567106571
• UDI-Public: 10607567106571
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2023
• Device Model Number: 0684-00-0480-02
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000115119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 04/30/2021; 06/10/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 05/03/2021; 05/21/2021; 06/10/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IABP CONSOLE #: SHP15676.
• Outcome Attributed to Adverse Event: Required Intervention