MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SAFESHEATH¿ SPLITTABLE SHEATH INTRODUCER; TEARAWAY SHEATH INTRODUCER

Model Number 00884450395943

Device Problem Material Deformation (2976)

Patient Problem Pseudoaneurysm (2605)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

A partial device was returned for evaluation.The complaint is confirmed.The root cause is related to damage of the needle cannula, but the source was unable to be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

Event Description

The account alleges that during several attempts to acquire percutaneous vascular access via the patient's subclavian vein, a hematoma and a pseudoaneurysm formed.The physician was unsuccessful in acquiring venous access with the guidewire and access needle.The hematoma was treated by the medical staff and a vascular stent was eventually placed by the physician to successfully treat the patient's pseudoaneurysm with no additional consequences to report.

• Brand Name: SAFESHEATH¿ SPLITTABLE SHEATH INTRODUCER
• Type of Device: TEARAWAY SHEATH INTRODUCER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern, pa
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern, pa
• Manufacturer Contact: david lockridge ; 1600 merit parkway; south jordan, ut ; 2084551
• MDR Report Key: 9772390
• MDR Text Key: 181922489
• Report Number: 2529252-2020-00003
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00884450395943
• UDI-Public: 00884450395943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 00884450395943
• Device Catalogue Number: KIT-051-02
• Device Lot Number: Q1547396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention