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

Catalog Number 41103510PIG-NB/JP

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

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

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device is 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 vascular procedure the tip of the catheter detached within the patient.The physician states that the catheter detached between a radiopaque marker and the tip of the shaft during catheter withdrawal.The physician successfully retrieved the detached catheter tip by hand.No further intervention was required.No patient injury 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®.NON-BRAIDED CATHETER
• Type of Device: PERIPHERAL CATHETERS
• MDR Report Key: 11051623
• MDR Text Key: 239384122
• Report Number: 3010665433-2020-00063
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450022436
• UDI-Public: 884450022436
• 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: 12/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2023
• Device Catalogue Number: 41103510PIG-NB/JP
• Device Lot Number: E1852036
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• 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: INTERVENTIONAL GUIDEWIRE.