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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENVOYDA CATHETER, PERCUTANEOUS

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MEDOS INTERNATIONAL SARL UNKENVOYDA CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number UNKENVOYDA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Type  Injury  
Manufacturer Narrative
Manufacturer¿s ref. No: (b)(4). Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided. Date of event: the date of the event/study is not known. The product catalog and lot numbers are not available / not reported. The unique identifier (udi) and expiration date of the device is not known. Information such as initial reporter facility name, address, city, state, name, phone and email address are not available / reported. The device manufacture date is not known as the product lot number of the device is not available / not reported. [conclusion]: it was reported through the database related research activities (drra) report source on behalf of the md-epidemiology, via study number: rwe20_saf_013, there were ten patients who underwent a neurovascular procedure for an unruptured intracranial aneurysm where the envoy distal access guiding catheter (unknown product code / lot# unknown) were used. The patients experienced intracranial bleeding at the time of the index procedure. The intracranial bleeding was not present on admission among patients treated for unruptured intracranial aneurysm. No other information is available. Based on complaint information, the device was not available to be returned for analysis. The device lot number was not available. The manufacturing documentation review could not be performed without the lot number. Product analysis cannot be conducted as the product was not returned for analysis. In addition, there was no report of malfunction associated with the device. As such, the investigation will be closed. Intracranial bleeding is considered serious and life threatening and can cause permanent damage/death or may require medical intervention to prevent permanent damage/death, the meets mdr reporting criteria. With extremely limited information available, the cause(s) of the cerebral artery occlusion or ischemic stroke complication is not known. There was no information on patient medical histories, and no information on the device and its performance during use in the study procedure and no information related to concomitant devices used during the procedure. The device catalog and lot numbers are not known; therefore, the determination of possible device-related causes cannot be determined through device analysis or through device history record review. The exact cause of the event could not be conclusively determined. As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time. Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time. This is one of five products involved with the reported complaint. The associated manufacturer report numbers are: 3008114965-2021-00003, 3008114965-2021-00004, 3008114965-2021-00005, 3008114965-2021-00006, and 3008114965-2021-00007. 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. Additional information will be submitted within 30 days of receipt.
 
Event Description
It was reported through the database related research activities (drra) report source on behalf of the md-epidemiology, via study number: rwe20_saf_013, there were ten patients who underwent a neurovascular procedure for an unruptured intracranial aneurysm where the envoy distal access guiding catheter (unknown product code / lot# unknown) were used. The patients experienced intracranial bleeding at the time of the index procedure. The intracranial bleeding was not present on admission among patients treated for unruptured intracranial aneurysm. No other information is available.
 
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Brand NameUNKENVOYDA
Type of DeviceCATHETER, PERCUTANEOUS
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 dr
irvine, CA 92618
949789-868
MDR Report Key11114300
MDR Text Key231152700
Report Number3008114965-2021-00007
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K140080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKENVOYDA
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2020
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 Treatment Data
Date Received: 01/04/2021 Patient Sequence Number: 1
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