MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKPROWLERSELECTLPES; CATHETER, CONTINUOUS FLUSH

Catalog Number UNKPROWLERSELECTLPES

Device Problem Peeled/Delaminated (1454)

Patient Problems Vasoconstriction (2126); Thromboembolism (2654); Ischemia Stroke (4418)

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Cerenovus manufacturer's report number: 2954740-2021-00006 are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent coiling of an unruptured aneurysm and the procedure was complicated by severe vasospasms in the supraclinoidal segment of the left internal carotid artery (ica).The patient was treated with 1 mg of intra-arterial nimotop.Furthermore, following the elective endovascular coiling of a left internal carotid artery aneurysm an mri revealed acute punctate cortical infarctions, and she was treated with intravenous thrombolysis with some effect.The mri showed evidence of an embolic phenomenon, probably from the polymer material.Nine weeks later, she was re-admitted after suffering a general tonic-clonic seizure.Mri showed diffuse t2 hyperintensity of the left cerebral hemisphere.Lamotrigine which was later switched to levetiracetam was started as anti-epileptic prophylactic.Oral prednisolone 100 mg once daily was started.Model and catalog number are not available, but the suspected device is the prolwer mc.Other cnv devices that were also used in this study: none.Non-cnv devices that were also used in this study: 4f vertebralis.Catheter (cook), 6f sheath (iva, balt), 017 sl-10 microcatheter (stryker), 5 mm x 10 mm copernic balloon (balt), 6f fargomax guiding catheter (balt), 017 headway duo microcatheter (microvention), and 4 mm x10 mm transform.Supercompliant balloon (stryker).Publication details: title: delayed leukoencephalopathy from suspected.Polymer embolism after neuroendovascular procedures.Objective: as the neurointervention field grows, a new side effect emerges.Delayed leukoencephalopathy (dl) is believed to be an inflammatory or allergic reaction to polymer material that is shed from catheters during endovascular procedures.Methods: we present four cases of dl after aneurysm treatment in two patients, endovascular stroke treatment and diagnostic arteriography.We present our diagnostic process, including biopsy results in two patients, our anti-inflammatory treatment and outcomes together with a review of the literature.

• Brand Name: UNKPROWLERSELECTLPES
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12540036
• MDR Text Key: 273565391
• Report Number: 3008114965-2021-00478
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNKPROWLERSELECTLPES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 017 HEADWAY DUO MICROCATHETER (MICROVENTION); 017 SL-10 MICROCATHETER (STRYKER); 4F VERTEBRALIS CATHETER (COOK); 5 MM X 10 MM COPERNIC BALLOON (BALT); 6F FARGOMAX GUIDING CATHETER (BALT); 6F SHEATH (IVA, BALT); X10 MM TRANSFORM BALLOON (STRYKER)
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 25 YR