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

Model Number 00884450009857

Device Problem Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device was not returned for evaluation.The root cause was attributed to use error as this device was not used in accordance with the ifu (instructions for 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 exception documents were found.

Event Description

The account alleges that a drainage system was implanted for the treatment of billions of digestive stenosis and after 8 weeks a leak was noted.When performing rx the product was normal and positioned correctly.The patient was treated with antibiotics and was scheduled for withdrawal on (b)(6).On the date, at the time of the initial fluoroscopy to remove the material, the fragmentation of the product was confirmed.Due to what happened, the drain was changed (and not removed), the treatment was extended for another two weeks.The fragments were removed with a loop catheter.The patient is fine.Doctor requested an opinion from the company.Product manager (b)(6) reported having contacted the doctor over the phone and in conversation, indicated that this catheter is not suitable for this type of implant.

• Brand Name: RESOLVE LOCKING DRAINAGE CATHETER
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, ut ; 2084662
• MDR Report Key: 10398854
• MDR Text Key: 202989321
• Report Number: 3010665433-2020-00028
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00884450009857
• UDI-Public: 00884450009857
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• 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: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 00884450009857
• Device Catalogue Number: RLC-12-038MB/B
• Device Lot Number: E1570589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2019
• 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
• Patient Age: 43 YR