MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PRELUDE SNAP; INTRODUCER, CATHETER

Model Number	10884450467951
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
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 a pacemaker lead extraction and upgrade, the prelude peel away sheath was used to maintain venous access and sutured down.During removal, the top of the sheath broke away.The surgeon cut down the incision site to remove the broken off sheath.No patient injury to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The device was examined visually, and functional testing was performed.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no complaints for this lot number were identified.

• Brand Name: PRELUDE SNAP
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• MDR Report Key: 10820168
• Report Number: 3011642792-2020-00013
• Device Sequence Number: 19714126
• Product Code: DYB
• UDI-Device Identifier: 10884450467951
• UDI-Public: 10884450467951
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K143255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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 Model Number: 10884450467951
• Device Catalogue Number: PLS-1006/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1