MAUDE Adverse Event Report: SOFIA FLOW 5F; PERCUTANEOUS CATHETER

Model Number DA5125ST

Device Problem Stretched (1601)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for analysis.The investigation is currently underway.

Event Description

It was reported that during aspiration with a sofia aspiration catheter and mechanical thrombectomy with a strent retriever, the sofia's inner wire was pulled out of the lumen.There was no reported patient injury or intervention.

Manufacturer Narrative

The investigation found loose metal filament wire throughout the catheter, consistent with the alleged product issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: SOFIA FLOW 5F
• Type of Device: PERCUTANEOUS CATHETER
• MDR Report Key: 12250804
• MDR Text Key: 264519905
• Report Number: 2032493-2021-00297
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00810170019234
• UDI-Public: (01)00810170019234(11)201016(17)230930(10)20101652A
• Combination Product (y/n): N
• PMA/PMN Number: K150366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: DA5125ST
• Device Catalogue Number: DA5125ST
• Device Lot Number: 20101652A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2020
• 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
• Patient Age: 71 YR
• Patient Weight: 66