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

Model Number	00884450009321
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2020
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 peripheral percutaneous transluminal revascularization procedure, the catheter tip detached within the patient.The clinician had acquired right retrograde arterial access and had negotiated the patient's right common iliac bifurcation with a guidewire and 5f catheter.During catheter manipulations within the right common iliac artery, the catheter tip detached.The physician used a vascular snare device to successfully retrieve the foreign body from the patient.The revascularization procedure was re-scheduled due to extensive radiation exposure and delay in procedure due to the additional [foreign body retrieval] procedure.The patient tolerated the procedure well and rescheduled for revascularization of the left lower limb.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, 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: 10059724
• Report Number: 3010665433-2020-00014
• Device Sequence Number: 14276195
• Product Code: DQO
• UDI-Device Identifier: 00884450009321
• UDI-Public: 00884450009321
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/23/2020

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: 09/30/2022
• Device Model Number: 00884450009321
• Device Catalogue Number: 565382CB1
• Device Lot Number: E1682874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/29/2020
• 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