MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. RESOLVE LOCKING DRAINAGE CATHETER

Catalog Number RLC-8-038

Device Problems Fracture (1260); Material Rupture (1546); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2019

Event Type  malfunction  

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 post-drainage tube placement, the tip of the drainage tube at the marker band, had detached within the patient's small intestine.The drainage tube was successfully replaced by the physician with no additional consequences to report.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was confirmed.The root cause is human error; this device is not intended for use within the biliary system.The ifu establishes the appropriate use and precautions for the catheter.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: RESOLVE LOCKING DRAINAGE CATHETER
• Type of Device: DRAINAGE CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 8897806
• MDR Text Key: 154582664
• Report Number: 3010665433-2019-00052
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RLC-8-038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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