MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GUIDE CATHETER; PERCUTANEOUS CATHETER

Catalog Number UNKENVOY

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  

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: (4) intracranial hemorrhage (2) hyperfusion postoperation (2) vessel perforation intra-op *specific interventions were not provided per adverse event.

Manufacturer Narrative

(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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: GUIDE CATHETER
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle nechatel CH240 0; SZ CH2400
• MDR Report Key: 12574110
• MDR Text Key: 281029815
• Report Number: 3008264254-2021-00040
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K000715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• 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: UNKENVOY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• 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