MAUDE Adverse Event Report: IMPRESS®.BRAIDED CATHETER; FG.PERIPHERAL CATHETERS

Catalog Number	412535VER
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
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 a peripheral vascular procedure, the catheter tip detached within the patient.The physician had successfully acquired retrograde arterial access and during catheter manipulations within the vasculature, over a guide wire, under fluoroscopy the catheter tip detached.The foreign body was successfully retrieved form the patient with vascular snare devices.A new catheter was used to complete the procedure for the patient.No additional consequences to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The device was examined visually and microscopically.Both the tip, shaft, and side of the joint, reveled material elongation indicating some level of tensile force had occurred.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Common Device Name: FG.PERIPHERAL CATHETERS
• MDR Report Key: 11813232
• Report Number: 3010665433-2021-00029
• Device Sequence Number: 3748057
• Product Code: DQO
• UDI-Device Identifier: 00884450020098
• UDI-Public: 884450020098
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: 11/11/2023
• Device Catalogue Number: 412535VER
• Device Lot Number: E1984250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• 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; GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention