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

Catalog Number	RLC-14-038MB/B
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Off-Label Use (1494)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that a drainage catheter was placed within a patient on (b)(6) 2021.The patient tolerated the procedure well.No injury to report.During a scheduled drainage catheter replacement / follow-up appointment procedure on (b)(6) 2021, the catheter was flushed with contrast under fluoroscopy, and a guidewire was inserted for the catheter exchange.When the physician attempted to remove the catheter, it was obvious that the original drainage catheter had detached within the patient's biliary system.The original catheter was removed, and a new catheter was placed successfully for the patient.The detached tip was left within the patient's biliary system.The physician stated that the foreign body would pass naturally through the patients gi track.The ifu states: the drainage catheter is not intended for use within the biliary system [operator "use error"].No additional consequences to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use and excessive force during 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.

• Brand Name: RESOLVE LOCKING DRAINAGE CATHETER
• Common Device Name: IRRIGATION CATHETER
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• MDR Report Key: 12338994
• Report Number: 3010665433-2021-00066
• Device Sequence Number: 3350523
• Product Code: GBX
• UDI-Device Identifier: 00884450009864
• UDI-Public: 884450009864
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 07/30/2021

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: 07/30/2021
• Device Catalogue Number: RLC-14-038MB/B
• Device Lot Number: E2076727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1