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

Model Number 0684-00-0480-01

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problems Fever (1858); No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

(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 Description

It was reported that during intra-aortic balloon (iab) therapy on a patient with st-segment elevation myocardial infarction (stemi), the balloon did not fully open.Augmentation of the patient is not as low as the first day of therapy.The doctor thought the balloon had ruptured.The balloon was removed from the patient.The company representative was notified by the facility of the incident and inquired with the doctor of the fever again.Subsequently, the company representative went to the hospital and printed out the alarm logs on the cs300 intra-aortic balloon pump (iabp).The following three alarms were found, alarm has no trigger, augmentation below limit set and triggers electrocardiogram (ekg).It appears that the patient had a fever, but is unclear if this is related to the alleged product issue.A separate report will be submitted for the cs300 iabp.

Event Description

It was reported that during intra-aortic balloon (iab) therapy on a patient with st-segment elevation myocardial infarction (stemi), the balloon did not fully open.Augmentation of the patient is not as low as the first day of therapy.The doctor thought the balloon had ruptured.The balloon was removed from the patient.The company representative was notified by the facility of the incident and inquired with the doctor of the fever again.Subsequently, the company representative went to the hospital and printed out the alarm logs on the cs300 intra-aortic balloon pump (iabp).The following three alarms were found, alarm has no trigger, augmentation below limit set and triggers electrocardiogram (ekg).We have received clarifying information that the patient had no fever and no injury.A separate report will be submitted for the cs300 iabp.

Manufacturer Narrative

Additional information: adverse event/product problem.From: adverse event & product problem.To: product problem.Type of reportable event.From: serious injury.To: malfunction.Patient codes.From: fever; 1858.To: no consequences or impact to patient; 2199.The device has not been returned to the manufacturer so we are unable to complete an evaluation.We are unable to confirm the reported event.If additional information is provided we will send a supplemental report with our additional findings.Reference complaint #(b)(4).Device not returned.

• Brand Name: LINEAR 7.5FR. 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10576534
• MDR Text Key: 208223910
• Report Number: 2248146-2020-00492
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: 10607567106564
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000107635
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 09/27/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 67