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

Catalog Number 46535BER

Device Problem Fracture (1260)

Patient Problems Renal Failure (2041); Foreign Body In Patient (2687)

Event Date 07/17/2017

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 temporary dialysis catheter placement procedure the diagnostic catheter tip detached within the patient's right subclavian vein.The physician had acquired right subclavian vein access and during catheter manipulations over a stiff guide wire the catheter tip detached.The physician then used a vascular snare device to successfully retrieve the diagnostic catheter tip from the patient via the right femoral vein.No injury to report.Another catheter was used to successfully finish the procedure.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually and microscopically and appeared to be cut.The complaint is confirmed.The root cause could not be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: IMPRESS ANGIOGRAPHIC CATHETER
• Type of Device: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston 77047
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan 84095
• MDR Report Key: 6764168
• MDR Text Key: 81725406
• Report Number: 3010665433-2017-00046
• 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: 07/17/2017

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: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 46535BER
• Device Lot Number: E1109342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2017
• 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): Required Intervention