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

Model Number	00884450281291
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional Manufacturer Narrative
A device was returned for evaluation.The complaint is confirmed.The root cause could not 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.

• Brand Name: SAFESHEATH SPLITTABLE SHEATH INTRODUCER
• Common Device Name: SPLITTABLE SHEATH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern, pa
• MDR Report Key: 9772392
• Report Number: 2529252-2020-00002
• Device Sequence Number: 3331905
• Product Code: DYB
• UDI-Device Identifier: 00884450281291
• UDI-Public: 00884450281291
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2022
• Device Model Number: 00884450281291
• 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 Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention