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

Model Number	00884450026571
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is 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 an interventional peripheral vascular procedure, the catheter detached within the patient.The physician had successfully acquired retrograde arterial access and negotiated the patient's common iliac bifurcation acquiring the vascular purchase necessary to treat the targeted calcified occlusion.During a catheter exchange attempt within the iliac artery, the 4f catheter tip detached.The physician was able to successfully retrieve the foreign body from the patient.The patient tolerated the procedure well with no additional consequences to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.No definitive root cause could be determined however, it is likely that significant force was 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 BRAIDED PERIPHERAL CATHETER
• Common Device Name: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 10370497
• Report Number: 3010665433-2020-00027
• Device Sequence Number: 19583596
• Product Code: DQO
• UDI-Device Identifier: 00884450026571
• UDI-Public: 00884450026571
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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: 06/30/2022
• Device Model Number: 00884450026571
• Device Catalogue Number: 46538BER
• Device Lot Number: E1621966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/26/2020
• 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: Required Intervention