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

Catalog Number 510038SIM2/CN

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges during a procedure the angiography tube broke into 2 sections.While attempting to remove the foreign bodies they broke again for a total of 4 pieces.An additional procedure was necessary to repair damage to the patient vasculature after removal of the pieces.There is no further patient consequence 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: PERIPHERAL CATHETERS
• MDR Report Key: 12134877
• MDR Text Key: 260463337
• Report Number: 3010665433-2021-00049
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450009307
• UDI-Public: 884450009307
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 510038SIM2/CN
• Device Lot Number: E1502935
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention