MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING RESOLVE LOCKING DRAINAGE CATHETER; RESOLVE DRAINAGE CATHETE

Catalog Number RLC-12-038MB/B

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

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

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that a drainage catheter fractured within a patient post implant procedure.The drainage catheter was originally implanted for treatment of digestive stenosis, and after 8 weeks a leak was identified.The patient was treated with antibiotics and was scheduled for a catheter removal procedure on (b)(6) 2020.During the removal procedure, the initial fluoroscopy images demonstrated that the catheter had also fragmented within the patient.The physician removed the detached catheter fragments successfully from the patient with snare device.The drainage catheter was exchanged [not removed] and treatment continued for another two weeks.The patient is doing well.

• Brand Name: RESOLVE LOCKING DRAINAGE CATHETER
• Type of Device: RESOLVE DRAINAGE CATHETE
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston, tx
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston, tx
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, ut ; 2084662
• MDR Report Key: 10457973
• MDR Text Key: 204517482
• Report Number: 3010665433-2020-00030
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00884450298022
• UDI-Public: 884450298022
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: RLC-12-038MB/B
• Device Lot Number: E1570589
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STIFF GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR