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

Catalog Number 59038UAC

Device Problems Material Fragmentation (1261); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  Injury  

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.

Event Description

The account alleges that during a fibroid embolization the physician torqued the catheter to the point it became severely twisted.In an attempt to untwist, a stiff guide wire was inserted to straighten the catheter.Without checking to make sure the catheter was straight, the catheter was pulled aggressively and detached in the distal end of the patient.The detached piece was successfully collected with a snare.No patient harm to report.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be 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.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12046713
• MDR Text Key: 263522252
• Report Number: 3010665433-2021-00045
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450109373
• UDI-Public: 884450109373
• Combination Product (y/n): N
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 59038UAC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention