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

Catalog Number 512535VER

Device Problems Fracture (1260); Material Separation (1562)

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

Event Date 11/22/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is not 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 Description

The account alleges that during a diagnostic neuro angiogram procedure, the catheter tip detached within the patient.The physician used a vascular snare device to successfully remove the foreign body from the patient with no additional patient consequences to report.

Manufacturer Narrative

The suspect device was not returned for evaluation.A photo attached to this case verifies that the catheter tip has separated.Since the tip is separated in the photo the complaint is confirmed.Review of attached photo showed two small elongated sections of the tip on both sides of the fracture.The root cause could not be determined however, it is likely that significant 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.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Type of Device: PERIPHERAL CATHETER
• MDR Report Key: 11020384
• MDR Text Key: 221785326
• Report Number: 3010665433-2020-00059
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450032541
• UDI-Public: 884450032541
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 512535VER
• Device Lot Number: E1708976
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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
• Treatment: GUIDEWIRE; GUIDEWIRE
• Patient Outcome(s): Required Intervention