MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS®.BRAIDED CATHETER; PERIPHERAL CATHETERS

Catalog Number	58038MIK/CN
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device will not be returning for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
Event or Problem Description
The account alleges that during a tace procedure, the 5f catheter detached within the patient.The physician had acquired retrograde arterial access and during catheter manipulations over a guidewire, under fluoroscopy the tip of the catheter detached within the patient iliac artery.The physician attempted to use a vascular snare device to externalized the foreign body but was unsuccessful.After capturing the foreign body with a vascular snare device, the foreign body fragmented into two additional pieces and migrated to the patient's lumbar artery and internal iliac artery.After clinical evaluation by experts and doctors, it was decided to leave the foreign bodies within the patient.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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: IMPRESS®.BRAIDED CATHETER
• Common Device Name: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15008980
• Report Number: 3010665433-2022-00072
• Device Sequence Number: 6856303
• Product Code: DQO
• UDI-Device Identifier: 00884450009420
• UDI-Public: 884450009420
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2023
• Device Catalogue Number: 58038MIK/CN
• Device Lot Number: E1780858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTERVENTIONAL GUIDWIRE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown