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

Catalog Number 4653510STF-NB

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/19/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a peripheral vascular thrombolytic therapy procedure, the catheter tip detached within the patient's common femoral vein.The physician had acquired left antegrade femoral vein access and during catheter manipulations over a guidewire when the catheter tip detached within the femoral vein.The catheter tip was migrating towards the patient's inferior vena cava during inspirations.The physician used a vascular snare device to successfully retrieve the catheter tip from the patient.The patient was not injured.

Manufacturer Narrative

One 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 exceptions documents were found.

• Brand Name: IMPRESS PERIPHERAL CATHETER
• Type of Device: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEM, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEM, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: ron boswell, b.s.-hca, rcis ; 1600 w. merit parkway; south jordan, UT 94095 ; 8012531600
• MDR Report Key: 7019445
• MDR Text Key: 91796508
• Report Number: 3010665433-2017-00075
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

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: No Information
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 4653510STF-NB
• Device Lot Number: E1193523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention