MAUDE Adverse Event Report: INNOVATIVE TRAUMA CARE, INC. ITCLAMP

Model Number	9100
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Codes	Hematoma (1884); Blood Loss (2597)
Date of Event	03/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The laceration caused a catastrophic injury requiring surgical intervention to repair.In the field, the wound was packed with a hemostatic gauze, closed with the itclamp and external direct pressure was held during transport.The wound location was not amenable to a tourniquet.The itclamp is a device for control of severe bleeding in the extremities, axilla, inguinal areas, scalp and neck.Patients must be seen promptly by medical personnel for device removal and surgical wound closure following use.
Event or Problem Description
It was reported that an itclamp was used to control external bleeding from a laceration in the junctional area of a (b)(6) year old male patient.The laceration caused a complete transection of his femoral artery and vein in the junctional area.Upon arrival at the emergency department, it was observed that the bleeding was continuing into the internal space resulting in an expanding hematoma.Bleeding control was obtained with direct pressure to the inguinal area.The volume of blood loss was potentially life-threatening.The femoral artery and vein were repaired during surgery.No further issues were reported.

• Brand Name: ITCLAMP
• Common Device Name: ITCLAMP
• Manufacturer (Section D): INNOVATIVE TRAUMA CARE, INC.; 18618 tuscany stone; suite 100; san antonio TX 78258
• MDR Report Key: 6720492
• Report Number: 3009810107-2017-00001
• Device Sequence Number: 985356
• Product Code: DXC
• UDI-Device Identifier: 00854874004004
• UDI-Public: 00854874004004
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2017

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?: No
• Operator of Device: Paramedic
• Device Model Number: 9100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CELOX HEMOSTATIC GAUZE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 15 YR
• Patient Weight: 65