MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number UNKNOWN

Device Problem Calibration Problem (2890)

Patient Problem Thrombus (2101)

Event Date 03/15/2019

Event Type  Injury  

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.(b)(4).

Event Description

It was initially reported on (b)(6) 2019 that during intra-aortic balloon (iab) therapy, an ¿unable to calibrate fiber-optic sensor¿ alarm and an ¿unable to update timing¿ alarm was generated by the console and therapy was temporarily interrupted.The specific catheter model was not available, however it was reported to be a sensation plus type.The clinician then switched to a non-invasive pressure monitoring source and therapy continued with no reported injury to the patient.Follow-up information provided on (b)(6) 2019 indicated that the patient had developed a large (blood) clot in the left atrium which had moved or was resolved once anticoagulation had been initiated.The customer felt that a clot had also likely been the cause of the inability of the iab catheter sensor to properly monitor pressures and was not going to return the catheter as therapy was ongoing and the issue had resolved.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 8483544
• MDR Text Key: 140949749
• Report Number: 2248146-2019-00271
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR