MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5FR. 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	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (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 intra-aortic balloon (iab) therapy, a leak occurred and blood backed into the cardiosave intra-aortic balloon pump (iabp).There was no patient harm or adverse event reported.This report is for the iab used in this event.A separate report has been submitted for the cardiosave iabp under mfg report number 2249723-2023-03275.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, a leak occurred and blood backed into the cardiosave intra-aortic balloon pump (iabp).It was also noted that the iabp had generated a low augmentation alarm.A new iab was inserted to continue therapy for three days.There was no patient harm or adverse event reported.This report is for the iab used in this event.A separate report has been submitted for the cardiosave iabp under mfg report number: 2249723-2023-03275.
Additional Manufacturer Narrative
Updated field(s): sex.Date of birth: age at time of event/ age units (patient).Weight./ weight (units).Describe event or problem.Other relevant history.Brand name: serial# / lot#./ catalog# / unique identifier (udi)#/ manufacture date/ exp.Date.Device available for eval? pma/510(k)#.The device will not be returned and cannot be evaluated.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id#: (b)(4).

• Brand Name: LINEAR 7.5FR. 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: 17435342
• Report Number: 2248146-2023-00481
• Device Sequence Number: 6779926
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: 10607567106557
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2023

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: 02/28/2026
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000300820
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 08/06/2023; 09/06/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/21/2023; 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• 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: CARDIOSAVE / CH226741A6.
• Patient Sex: Female
• Patient Weight: 49 KG