MAUDE Adverse Event Report: MERIT MEDICAL PEARLAND IMPRESS PERIPHERAL CATHETER; PERIPHERAL CATHETER,

Catalog Number 56538KA2

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/12/2018

Event Type  malfunction  

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 percutaneous transhepatic cholangiography [ptc] procedure, the catheter tip detached within the patients biliary system.The physician was trying to exchange the catheter over an.035 guidewire when the catheter tip detached.A vascular snare device was used to successfully retrieve the catheter tip from the patient.An additional catheter was used to successfully finish the procedure.

Manufacturer Narrative

One device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.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.Corrective actions are in process.

• Brand Name: IMPRESS PERIPHERAL CATHETER
• Type of Device: PERIPHERAL CATHETER,
• Manufacturer (Section D): MERIT MEDICAL PEARLAND; 14646 kirby dr.; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL PEARLAND; 14646 kirby dr.; houston TX 77047
• Manufacturer Contact: casey hughes ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 7201125
• MDR Text Key: 97986791
• Report Number: 3010665433-2018-00004
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 56538KA2
• Device Lot Number: E1227863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• 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