BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 6016313 · Received October 11, 2016

    Report

    Report Number
    3004193842-2016-00015
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    October 30, 2015
    Report Date
    October 7, 2016
    Manufacturer
    CREGANNA MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REVIEW COULD NOT CONFIRM THE REPORTED COMPLAINT AS THE DEVICE WAS NOT RECEIVED FOR REVIEW. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LOT # 268574 DID NOT HIGHLIGHT ANY ANOMALY WHICH COULD CONTRIBUTE TO THIS REPORTED EVENT. A SIMILAR COMPLAINT TREND REVIEW HAS BEEN COMPLETED. NO FURTHER COMPLAINTS HAVE BEEN OPENED SPECIFIC TO LOT 268574. NO TREND IDENTIFIED FROM THIS REVIEW. FROM THE INFORMATION AVAILABLE, THERE IS NOTHING TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. BASED ON THE COMPLAINT REVIEW AND THE EVENT DESCRIPTION FOR THIS COMPLAINT, THE ROOT CAUSE CLASSIFICATION CODE ASSIGNED TO THIS COMPLAINT IS, 'ANTICIPATED PROCEDURAL COMPLICATION'. ANTICIPATED PROCEDURAL COMPLICATION IS DEFINED AS WHERE 'THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE INSTRUCTIONS FOR USE, AND OR DEVICE LABELLING'. VESSEL DISSECTION IS DOCUMENTED AS A POTENTIAL ADVERSE EFFECT WITHIN THE LOTUS DFU 139816-01 AND IS AN ANTICIPATED PROCEDURAL COMPLICATION DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS NOTED WITHIN THE INSTRUCTIONS FOR USE. BASED ON A REVIEW OF THE FMEAS AND BASED ON THIS COMPLAINT INVESTIGATION, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE LOTUS INTRODUCER SHEATH AT THIS TIME. THERE IS NO INDICATION OF A POTENTIAL PROCESSING, DESIGN OR USE FAILURE ASSOCIATED WITH THIS COMPLAINT. VESSEL DISSECTION IS CONSIDERED IN MULTIPLE PLACES WITHIN THE RISK DOCUMENTATION AND IS NOT A NEW OR UNANTICIPATED FAILURE MODE. CREGANNA MEDICAL WILL CONTINUE TO MONITOR OCCURRENCE RATES PER THE RISK DOCUMENTATION. BASED ON THE ABOVE CONCLUSION, NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CREGANNA MEDICAL WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    RESPOND (B)(4) (DISSECTION OF THE AFC RIGHT SIDE DURING PROCEDURE DUE TO INTRODUCER SHEAT.) EVENT DESCRIPTION: DISSECTION OF THE AFC RIGHT SIDE DURING PROCEDURE DUE TO INTRODUCER SHEAT (001- VASCULAR COMPLICATIONS): ON (B)(6) 2015, DURING THE INDEX PROCEDURE, ULTRASOUND REVEALED DISSECTION OF THE RIGHT COMMON FEMORAL ARTERY DUE TO INTRODUCER SHEATH. PER EDC, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (WITHOUT STENTING) WAS PERFORMED TO TREAT THE EVENT. VARC CLASSIFICATION OF THE VASCULAR COMPLICATION: MINOR. PER EDC, THE TYPE OF INJURY WAS "UNPLANNED ENDOVASCULAR, SURGICAL INTERVENTION OR VASCULAR REPAIR NOT MEETING THE CRITERIA FOR MAJOR COMPLICATION (VIA SURGERY, ULTRASOUND-GUIDED COMPRESSION, TRANSCATHETER EMBOLIZATION, OR STENT-GRAFT)." ON (B)(6)2015, THE EVENT WAS CONSIDERED RECOVERED/ RESOLVED. ON (B)(6) 2015, SUBJECT WAS DISCHARGED ON CLOPIDOGREL AND OTHER COAGULANT. POTENTIAL RELATIONSHIP TO STUDY PROCEDURE PER INVESTIGATOR: RELATED.

    Description of Event or Problem · 1

    RESPOND (B)(4) (DISSECTION OF THE AFC RIGHT SIDE DURING PROCEDURE DUE TO INTRODUCER SHEAT.) EVENT DESCRIPTION: DISSECTION OF THE AFC RIGHT SIDE DURING PROCEDURE DUE TO INTRODUCER SHEAT (001- VASCULAR COMPLICATIONS): ON (B)(6) 2015, DURING THE INDEX PROCEDURE, ULTRASOUND REVEALED DISSECTION OF THE RIGHT COMMON FEMORAL ARTERY DUE TO INTRODUCER SHEATH. PER EDC, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (WITHOUT STENTING) WAS PERFORMED TO TREAT THE EVENT. VARC CLASSIFICATION OF THE VASCULAR COMPLICATION: MINOR. PER EDC, THE TYPE OF INJURY WAS "UNPLANNED ENDOVASCULAR, SURGICAL INTERVENTION OR VASCULAR REPAIR NOT MEETING THE CRITERIA FOR MAJOR COMPLICATION (VIA SURGERY, ULTRASOUND-GUIDED COMPRESSION, TRANSCATHETER EMBOLIZATION, OR STENT-GRAFT)." ON (B)(6) 2015, THE EVENT WAS CONSIDERED RECOVERED/ RESOLVED. ON (B)(6) 2015, SUBJECT WAS DISCHARGED ON CLOPIDOGREL AND OTHER COAGULANT. POTENTIAL RELATIONSHIP TO STUDY PROCEDURE PER INVESTIGATOR: RELATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668229 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL H749NTR180 268574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention