MAUDE Adverse Event Report: SOFIA DISTAL ACCESS CATHETER (DA5125ST); PERCUTANEOUS CATHETER/ DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number DA5125ST

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Coma (2417)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Telephone number: (b)(6).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.Investigation is ongoing.

Event Description

It was reported that treatment of the posterior fossa a scepter mini balloon catheter was tracked through a sofia 5f 125cm catheter to the right vertebral artery and posterior inferior cerebellar artery (pica) bifurcation.The scepter mini was inflated in the pica.Onyx was injected through the scepter mini to embolize a tumor of the posterior fossa.The onyx refluxed around the balloon to a level 2mm proximal to the scepter mini's proximal balloon marker.The scepter mini was pulled out of the cast but the scepter mini could not be withdrawn from the onyx cast.The sofia 5f was tracked into the pica to support the removal of the scepter mini, however both became irremovable and the patient was moved to neurosurgery for assistance with removal of the scepter mini and sofia and the planned excision of the tumor was brought forward to be carried out during the craniotomy.Patient had surgical intervention performed by craniotomy in neurosurgery to remove the catheters.The patient was comatose for 3 days post neurosurgical excision of their tumor post-embolization.As of the (b)(6), 11 days post op, the patient is weak and has not fully woken up.

Manufacturer Narrative

The reported complaint is confirmed.The physical evaluation of the returned devices found the scepter mini balloon catheter could not be withdrawn from the sofia, as received.The sofia was returned with significant damage at the distal tip (the distal tip was severed prior to receipt and the marker band was crushed).Due to this damage, replication testing could not be performed, but if the device was damaged like this during the reported event, the scepter would experience difficulties during retraction.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.The device was used during the same procedure as was reported in mfr.Report# 2032493-2021-00204.

Manufacturer Narrative

Additional information: the physician related that the patient is still alive.

• Brand Name: SOFIA DISTAL ACCESS CATHETER (DA5125ST)
• Type of Device: PERCUTANEOUS CATHETER/ DIAGNOSTIC INTRAVASCULAR CATHETER
• MDR Report Key: 11823283
• MDR Text Key: 250600219
• Report Number: 2032493-2021-00205
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00810170019234
• UDI-Public: (01)00810170019234(11)201112(17)231031(10)20111252R
• Combination Product (y/n): N
• PMA/PMN Number: K131482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: DA5125ST
• Device Catalogue Number: DA5125ST
• Device Lot Number: 20111252R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Date Manufacturer Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 79 YR