MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS PERIPHERAL CATHETER

Catalog Number	510038VER
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2019
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 a varicocele embolization procedure, vascular access gained at the right internal jugular vein under ultrasound guidance.A 5french sheath was inserted for procedural intervention.A 5f 100cm catheter was advanced into the left internal spermatic vein.The tip of catheter successfully opacified the distal left internal spermatic vein.Embolization coils were deployed at the inguinal region as planned.During an attempt to deploy a 6th coil, resistance was experienced.The physician was unable to deploy the 6th coil despite multiple attempts.The decision was made to extract the catheter and deploy the coil directly through the access sheath.Some resistance was felt during catheter removal.The catheter tip fractured accidently deploying the coil within the patient's right atrium.Several attempts to retrieve fragmented coil failed.Migration and distal embolization into the right pulmonary artery were possible.The patient was emergently transferred to a sister hospital for further intervention and foreign body removal.The coil and the catheter tip were successfully retrieved with a vascular snare device.The patient tolerated the procedure well and was discharged to home.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined physically.The complaint is confirmed.The root cause was attributed to significant force being applied to the device during use.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: IMPRESS PERIPHERAL CATHETER
• Common Device Name: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 9385093
• Report Number: 3010665433-2019-00081
• Device Sequence Number: 469497
• Product Code: DQO
• UDI-Device Identifier: 00884450009222
• UDI-Public: 884450009222
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: 09/30/2021
• Device Catalogue Number: 510038VER
• Device Lot Number: E1433768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 03/06/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 90