MAUDE Adverse Event Report: IMPRESS BRAIDED PERIPHERAL CATHETER; PERIPHERAL CATHETER,

Model Number	00884450023181
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
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 aortic [aaa] [evar] repair the tip detached.The unit was used for a stent-graft procedure.After the use of the catheter, it was pulled out from the patient.However, the black tip immediately detached after withdrawal from the patient outside the body.No fragment remained in the patient.No patient injury.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed 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 PERIPHERAL CATHETER
• Common Device Name: PERIPHERAL CATHETER,
• MDR Report Key: 10483305
• Report Number: 3010665433-2020-00033
• Device Sequence Number: 11441661
• Product Code: DQO
• UDI-Device Identifier: 00884450023181
• UDI-Public: 00884450023181
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2023
• Device Model Number: 00884450023181
• Device Catalogue Number: 56538VER/JP
• Device Lot Number: E1828902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 11/17/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2020
• 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