MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS DIAGNOSTIC CATHETER; INTRAVASCULAR DIAGNOSTIC CATHETER

Model Number	00884450109373
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
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 alleged that during a uterine artery embolization (uae) procedure, the catheter fractured within the patient's left internal iliac artery.The embolization procedure was aborted and catheter tip recovery was attempted with a vascular snare device via femoral artery access.The catheter tip fragmented again during this process and the endovascular removal was unsuccessful.The patient was referred for surgical removal.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause could not be determined.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 DIAGNOSTIC CATHETER
• Common Device Name: INTRAVASCULAR DIAGNOSTIC CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 9735316
• Report Number: 3010665433-2020-00004
• Device Sequence Number: 19433398
• Product Code: DQO
• UDI-Device Identifier: 00884450109373
• UDI-Public: 00884450109373
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/24/2020

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: 01/31/2020
• Device Model Number: 00884450109373
• Device Catalogue Number: 59038UAC
• Device Lot Number: E1093818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 75