MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE ROADSTER¿.; CATHETER, IRRIGATION

Catalog Number	PG6F45S
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that during a peripheral vascular intervention procedure, the tip of the dilator detached.During preparation of the primary access sheath, the sheath was manually curved by clinical staff with a 10cc syringe, with the dilator in place.The physician had successfully acquired contralateral retrograde right femoral artery access via the "seldinger technique" with the primary access sheath and had negotiated the patient's right iliac bifurcating conduit crossing over the iliac arch and accessing the left antegrade iliac conduit over a stiff angled.035x260 guidewire, under fluoroscopy.The introducer was then removed from the sheath.After removal, the supporting clinical staff noted that the tip looked "blunted" causing the attending clinician to further investigate the introducer confirming the tip of the introducer had detached.Additional fluoroscopy was necessary as they attempted to unsuccessfully locate the detached tip within the patient's anatomy.The clinician then attached a 20cc syringe to the hub of the primary access sheath and continuously aspirated while removing the access sheath from the patient's anatomy.The clinician held pressure while the primary access site was secured by temporarily placing a separate 6f sheath.The primary access sheath was investigated further by the clinical team.A syringe was connected to the end of the access sheath and vigorously flushed.The detached dilator tip was successfully located as it was flushed from within the primary access sheath.A competitor's sheath was then placed, and the procedure was successfully completed for this patient.
Additional Manufacturer Narrative
The suspect device has returned for investigation.A follow-up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
The suspect medical device was returned for evaluation.The device was visually and microscopically investigated and functional testing was performed.The complaint is confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: PRELUDE ROADSTER¿.
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15685482
• Report Number: 1721504-2022-00102
• Device Sequence Number: 7368029
• Product Code: GBX
• UDI-Device Identifier: 00884450531969
• UDI-Public: 884450531969
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: 09/30/2024
• Device Catalogue Number: PG6F45S
• Device Lot Number: H2418685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTERVENTIONAL GUIDEWIRE
• Patient Sex: Unknown