MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - MEXICO .IMPRESS®.BRAIDED CATHETER; PERIPHERAL CATHETERS

Catalog Number	56535RIM/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Separation Problem (4043)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	10/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that a catheter tip likely detached within a patient during a scheduled right leg angiogram/possible angioplasty on (b)(6) 2024.During this procedure, the physician attempted to access via the right femoral artery however, it was noted that the patient had severe calcification within the right common femoral artery [cfa], superficial femoral artery [sfa], and the right external iliac artery [eia].The physician then acquired secondary retrograde left femoral artery access with 6fx45cm sheath for extra support.The clinician was successful in advancing both the.035 glidewire and 5f catheter under fluoroscopy during the right ilio-femoral artery crossover- technique to acquire access to the targeted right femoral artery.The procedure was successfully completed at this time without the attending medical staff noticing the accidental iatrogenic foreign body [ifb] introduction.The angiogram and angioplasty were successfully performed on the patient's right eia, and right sfa.The patient underwent a secondary femoral artery endarterectomy procedure on (b)(6) 2024.The attending medical staff noted the iatrogenic foreign body [ifb] that was inadvertently left within the patient was identified when reviewing post-procedure images of the procedure that occurred on (b)(6) 2024.The physician successfully externalized the ifb from the patient's right femoral artery via a surgical cut-down technique thus liberating the vessel.The patient tolerated the procedure well with no additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A supplemental report will be submitted once the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed, and the root cause is attributed to a weak fuse joint related to the manufacturing process.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 SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton rn ; 1600 merit pky; south jordan 84095
• MDR Report Key: 20689679
• Report Number: 3011642792-2024-00075
• Device Sequence Number: 8701196
• Product Code: DQO
• UDI-Device Identifier: 00884450654538
• UDI-Public: 884450654538
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/04/2024

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 Catalogue Number: 56535RIM/B
• Device Lot Number: I2898443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male