MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PRELUDE IDEAL 6F HYRDOPHILIC; INTRODUCER, CATHETER

Model Number	PID6F11018NTPD
Health Effect - Clinical Codes	Pain (1994); Skin Discoloration (2074)
Date of Event	10/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
70y/o male scheduled for lhc (left heart catheterization) due to abnormal findings diagnostic imaging and coronary circulation.Hx (history of coronary artery disease) of cad, hf (heart failure), htn (hypertension), hyperlipidemia, sss (sick sinus syndrome), s/p pacemaker implant.On (b)(6) 2022 s/p lhc: findings non obstructive coronary artery disease, normal ef (ejection fraction) 55% and lvedp (left ventricular end diastolic pressure).Tx: medical management lhc report: dr.: "the tip of the access wire broke and i decided to perform femoral approach.We will perform ultrasound of the right forearm to evaluate for patency of ulnar and radial arteries." patient in cath lab holding room, s/p ultrasound of right upper extremity arterial doppler: results: patent radial and ulnar arteries as clinically questioned.Dr.Aware, and will discharge patient.Dr.Spoke to patient and family on the phone, relayed us (ultrasonogram)results and will follow up patient in 1 week.Gave instructions to patient if severe pain and loss of sensation and color changed on the hands to immediately go to nearest emergency room.Medical director of cath lab was notified recommend us (ultrasonogram) and if with good results, patent flow may discharge and follow up as op (outpatient).The broken wire and original wrapper was saved and collected.It is from merit medical.Prelude hydrophilic ideal 6 french sheath introducer kit 21gx4cm 11 cm with 0.018 wire.Reference # pid6f11018ntpd lot # h2441468.On (b)(6) 2022 @ 10:40 am spoken to merit account executive (b)(6) and reported incident.(b)(6).He will report the incident and will provide next steps.May need to investigate the product and be sent out to merit.Awaiting instructions from merit.Discharged home today, no pain, hematoma or bleeding noted both right radial and right femoral sites.Fda safety report id #(b)(4).

• Brand Name: PRELUDE IDEAL 6F HYRDOPHILIC
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS
• MDR Report Key: 15754803
• Report Number: MW5113152
• Device Sequence Number: 5132762
• Product Code: DYB
• UDI-Device Identifier: 00884450523070
• UDI-Public: (01)00884450523070
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2025
• Device Model Number: PID6F11018NTPD
• Device Lot Number: H2441468
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White