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

Model Number 00884450009321

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: INTRAVASCULAR DIAGNOSTIC CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 10059724
• MDR Text Key: 191083416
• Report Number: 3010665433-2020-00014
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450009321
• UDI-Public: 00884450009321
• Combination Product (y/n): N
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention