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

Catalog Number	56538BER-H
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
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 catheter tip detached within the patient.The physician successfully removed the foreign body form the patient with no additional consequences to report.
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 review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: IMPRESS®.BRAIDED ANGIOGRAPHIC CATHETER
• Common Device Name: PERIPHERAL CATHETERS
• MDR Report Key: 11629366
• Report Number: 3010665433-2021-00018
• Device Sequence Number: 19672078
• Product Code: DQO
• UDI-Device Identifier: 00884450043745
• UDI-Public: 884450043745
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K093004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 10/06/2023
• Device Catalogue Number: 56538BER-H
• Device Lot Number: E1962604
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• 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