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

Model Number	00884450009482
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that post-drainage catheter placement within the patient's biliary system, the drainage catheter became damaged at the bend 15 days later and would not continue to drain.The drainage catheter was replaced for this patient.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause was determined to be off-label use.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
• Common Device Name: DRAINAGE CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 10609999
• Report Number: 3010665433-2020-00036
• Device Sequence Number: 1192768
• Product Code: GBX
• UDI-Device Identifier: 00884450009482
• UDI-Public: 00884450009482
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 00884450009482
• Device Catalogue Number: RLC-8-038/CNB
• Device Lot Number: E1620806
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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