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

Catalog Number UNKPROWLERSELECT

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This complaint is from a literature source and the following citation was reviewed: lee j.Eso-wso 2020 joint meeting abstracts.International journal of stroke.2020;15(1_suppl):3-752.Catalog and lot #: the product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Initial reporter name and address: the initial reporter contact information is not available.Device manufacture date: the device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

This complaint is from a literature source and the following citation was reviewed: lee j.Eso-wso 2020 joint meeting abstracts.International journal of stroke.2020;15(1_suppl):3-752.Objective and methods: a case of emergency microsurgical embolectomy and extracranial to intracranial (ec-ic) bypass surgery for a case of complicated intra-arterial thrombectomy of a middle cerebral artery (mca) occlusion.Lot, model, and catalog number are not available, but the suspected cerenovus device is possibly associated with reported adverse events: prowler select plus microcatheter other concomitant cerenovus devices that were also used in this study: n/a non-cerenovus concomitant devices that were also used in this study: synchro-14 microwire (stryker), 3-mm arteriotomy (medtronic), right-angled clip (brand unknown) adverse event(s) and provided interventions: a (b)(6) male patient presented with right hemiparesis and global aphasia at 40 minutes from the onset of symptoms.The baseline nihss score was 20.Left m2 occlusion was confirmed by cerebral angiography, and interventional thrombectomy was planned.Under the local anesthesia, the prowler select plus microcatheter was navigated through the occlusion segment using synchro-14 microwire.Super selective angiography through the microcatheter showed contrast leakage into the sylvian fissure.Then we decided to perform microsurgical navigation to detect vascular injury and embolectomy.The embolus was removed via 3-mm arteriotomy.Icg angiography and intra-operative angiography showed recanalized m2 flow but also revealed delayed flow of precentral artery.Then sta-mca bypass surgery was done at the precentral branch by using the prepared parietal branch of sta.The patient's post-operative nihss score was 5.At discharge, the nihss score was 3.

• Brand Name: UNKPROWLERSELECT
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14567012
• MDR Text Key: 293343077
• Report Number: 3008114965-2022-00395
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K021591
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKPROWLERSELECT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2022
• 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: 3-MM ARTERIOTOMY (MEDTRONIC); RIGHT ANGLED CLIP (BRAND UNKNOWN); SYNCHRO-14 MICROWIRE (STRYKER)
• Patient Outcome(s): Required Intervention