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

Catalog Number	510038CB2/CN
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a uterine artery embolization [uae] procedure the catheter tip detached within the patient's artery.The physician acquired vascular access via seldinger technique to insert the 5f sheath using a pig tail catheter to enter the lower part of the abdominal aorta for fluoroscopic imaging.The bilateral uterine arteries were obviously thickened and tortuous.The 5f angiography catheter was inserted through the sheath, and an ultra-smooth guide wire was used to perform the angiography of the left internal iliac artery.It was found that the anterior segment of the angiography catheter had kinked and bent.During an attempt to gently withdraw the angiography catheter it completely detached within the patient.After inserting a vascular snare device, the broken angiography catheter was successfully captured.When trying to remove the angiography catheter, again the foreign body ruptured.Fluoroscopic inspection demonstrated that a 10mm foreign body remains within the terminal branch of the left deep femoral artery.Several attempts were made to retrieve the foreign body, but they were unsuccessful.General surgery was consulted for emergent surgical extraction of the remaining foreign body.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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 ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 13050105
• Report Number: 3010665433-2021-00126
• Device Sequence Number: 3912889
• Product Code: DQO
• UDI-Device Identifier: 00884450035832
• UDI-Public: 884450035832
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: 510038CB2/CN
• Device Lot Number: E1783959
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• 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: GUIDEWIRE.
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown