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

Model Number	00884450009857
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 10398854
• Report Number: 3010665433-2020-00028
• Device Sequence Number: 2963583
• Product Code: GBX
• UDI-Device Identifier: 00884450009857
• UDI-Public: 00884450009857
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR