MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKPROWLER; MICROCATHETER

Catalog Number UNKPROWLER

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

Patient Problems Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Perforation of Vessels (2135)

Event Date 09/03/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Literature citation: ¿diabetes mellitus does not increase the risk of adverse long-term outcomes after intracranial stent placement¿ reviewed.Li bh, yin yw, gao cy, hu zc, wang jh, zhang ll, li jc.Cell biochem biophys.2015 jan;71(1):413-8.Doi: 10.1007/s12013-014-0214-z.Pmid: 25182003.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.

Event Description

Literature article ¿diabetes mellitus does not increase the risk of adverse long-term outcomes after intracranial stent placement¿ reviewed.Li bh, yin yw, gao cy, hu zc, wang jh, zhang ll, li jc.Cell biochem biophys.2015 jan;71(1):413-8.Doi: 10.1007/s12013-014-0214-z.Pmid: 25182003.Objective and methods: ¿the present study is to investigate whether diabetes mellitus (dm) increases risk of adverse long-term outcomes after intracranial stent placement.Patients receiving intracranial stenting were assigned to dm group and non-dm group according to diabetes status.¿ ¿a total of 44 stenoses in 43 patients were retrospectively analyzed.¿ ¿after adjusting for the confounders, the risk of dm versus non-dm for composite outcomes remained insignificant.¿ ¿there is no evidence that dm increases the risk of adverse long-term outcomes after intracranial stent placement¿.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: prowler14 microcatheter cordis, 6f-guiding catheter envoy cordis.Other cerenovus devices that were also used in this study: n/a.Non-cerenovus devices that were also used in this study: 0.01400 micro-guide wire, wizdom, 0.01400 micro-guide wire, transcend-14, balloon catheters ryujinplus, terum, balloon-expandable stents, apollo, microport, guidant mimi vision, guidant, clearflex, clenrstream.Invastent, volo.Adverse event(s) and provided interventions: intracranial hemorrhage, hyperfusion postoperation, vessel perforation intra-op, specific interventions were not provided per adverse event.

• Brand Name: UNKPROWLER
• Type of Device: MICROCATHETER
• 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 ; 9497898687
• MDR Report Key: 12574111
• MDR Text Key: 274705210
• Report Number: 3008114965-2021-00496
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K003925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKPROWLER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 10/05/2021
• 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: 0.01400 MICRO-GUIDE WIRE, TRANSCEND-14; 0.01400 MICRO-GUIDE WIRE, WIZDOM; BALLOON CATHETERS RYUJINPLUS, TERUM; BALLOON-EXPANDABLE STENTS, APOLLO, MICROPORT; CLEARFLEX, CLENRSTREAM; GUIDANT MIMI VISION, GUIDANT; INVASTENT, VOLO
• Patient Outcome(s): Life Threatening