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

Catalog Number	PSI-6F-11-018/CN
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be 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.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a percutaneous transluminal angioplasty procedure, the access guidewire detached.The physician was attempting to acquire retrograde radial artery access and after removing the vascular access wire along with the sheath introducer, the physician noticed that the tip was missing.An x-ray revealed that the guidewire tip had detached within the patient's subcutaneous tissue.

• Brand Name: PRELUDE SHEATH INTRODUCER
• Common Device Name: SHEATH INTRODUCER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 9566268
• Report Number: 1721504-2020-00002
• Device Sequence Number: 14002452
• Product Code: DRE
• UDI-Device Identifier: 00884450008096
• UDI-Public: 884450008096
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2021
• Device Catalogue Number: PSI-6F-11-018/CN
• Device Lot Number: H1409902
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1