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

Catalog Number	512535HH1
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
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 a chemo embolization procedure, the device fractured into two pieces.The procedure was completed using the same device.There was no patient injury to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.A photograph was provided by the account.The complaint is confirmed.The root cause could not be determined.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: PERIPHERAL CATHETERS
• MDR Report Key: 12513240
• Report Number: 3010665433-2021-00074
• Device Sequence Number: 3937598
• Product Code: DQO
• UDI-Device Identifier: 00884450032534
• UDI-Public: 884450032534
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 12/30/2022
• Device Catalogue Number: 512535HH1
• Device Lot Number: E1752818
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• 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