MAUDE Adverse Event Report: IMPRESS®.BRAIDED.CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	46535BER
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
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 follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a peripheral vascular intervention the catheter tip detached within the patient.The physician had successfully acquired retrograde femoral artery access and had negotiated the patient's common iliac bifurcation [up & over tech.] with an interventional guide wire and the 4f catheter.During a guide wire exchange, the catheter tip detached within the patient's left superficial femoral artery [sfa].This event required an additional foreign body retrieval procedure.The patient tolerated the procedure well.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The tip that detached from the catheter was evaluated under magnification and was noted to be elongated, however, the fuse joint itself was intact.The complaint is confirmed.The root cause could not be determined however, it is likely that excessive 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: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10985422
• Report Number: 3010665433-2020-00052
• Device Sequence Number: 3562254
• Product Code: DQO
• UDI-Device Identifier: 00884450020012
• UDI-Public: 884450020012
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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: 02/20/2023
• Device Catalogue Number: 46535BER
• Device Lot Number: E1785500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 03/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention