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

Model Number	00884450028957
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
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 during an endovascular aortic repair [evar] procedure, the catheter tip detached within the patient.The physician had successfully navigated the ilio-femoral conduit to acquire final images of the scaffolding-graft that had been successfully deployed.A pig tail catheter was advanced under fluoroscopy and positioned just superior to patient's renal artery ostium.A power injection was completed.The attending medical staff did not notice that the pig tail catheter tip had detached until the catheter had been extracted from the patient vascular system.The physician successfully externalized the foreign body with a vascular snare device liberating the patient's aortic native conduit.The physician noted that the patients targeted vasculature system was unremarkable and experienced no difficulties while advancing and manipulating the 5f pigtail catheter.One device is returning for investigation.No additional patient consequences to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, 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®.NON-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; 8012084662
• MDR Report Key: 14438351
• Report Number: 3010665433-2022-00049
• Device Sequence Number: 5758824
• Product Code: DQO
• UDI-Device Identifier: 00884450028957
• UDI-Public: 00884450028957
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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): 05/12/2022

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 Model Number: 00884450028957
• Device Catalogue Number: 51103810PIG-NB
• Device Lot Number: E1925154
• 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: 05/12/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 09/15/2022
• 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 Sex: Unknown