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

Catalog Number	0684-00-0474
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: msn, aprn-cns, accns-ag, ccrn, advanced practice registered nurse , advance practice nursing (b)(6).Additional reporter: (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 that during therapy, an intra-aortic balloon (iab) rupture occurred and a surface-enhanced raman spectroscopy (sers) was placed.The insertion was reported to be axillary, which is not the method described in the device instructions for use.It was noted that the patient had multiple ruptures with replacements and after this one they were placing an impella.There was no patient harm or adverse event reported.This report is for the 1st iab.A separate report will be submitted for the 2nd iab.
Event or Problem Description
It was reported that during therapy, an intra-aortic balloon (iab) rupture occurred and a surface-enhanced raman spectroscopy (sers) was placed.The insertion was reported to be axillary, which is not the method described in the device instructions for use.It was noted that the patient had multiple ruptures with replacements and after this one they were placing an impella.There was no patient harm or adverse event reported.This report is for the 1st iab.A separate report will be submitted for the 2nd iab.Event description received from medwatch # 3601800000-2023-8012 iabp rupture.Iabp emergently removed and replaced.Axillary placement.
Additional Manufacturer Narrative
Updated field(s): sex age at time of event / age units weight./ weight (units) describe event or problem lot # device available for eval? exp date/ manufacture date additional reporter: (b)(6) | nurse manager | heart failure and coronary intensive care unit | email: (b)(6) additional reporter: (b)(6) additional reporter: (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 that during therapy, an intra-aortic balloon (iab) rupture occurred and a surface-enhanced raman spectroscopy (sers) was placed.The insertion was reported to be axillary, which is not the method described in the device instructions for use.It was noted that the patient had multiple ruptures with replacements and after this one they were placing an impella.There was no patient harm or adverse event reported.This report is for the 1st iab.A separate report has been submitted for the 2nd iab under mfg report number 2248146-2023-00520.Event description received from medwatch # (b)(4).Iabp rupture.Iabp emergently removed and replaced.Axillary placement.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 17584808
• Report Number: 2248146-2023-00518
• Device Sequence Number: 20034241
• Product Code: DSP
• UDI-Device Identifier: 10607567109503
• UDI-Public: 10607567109503
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2023

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: 06/20/2025
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000250770
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 10/11/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/11/2023; 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2022
• 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: IMPELLA
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 33 KG