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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SARL GUIDE CATHETER PERCUTANEOUS CATHETER Back to Search Results
Catalog Number UNKENVOY
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Manufacturer Narrative
Manufacturer's ref. No: (b)(4). Literature citation: goh dh, jin sc, jeong hw, ha sy. Mechanical solitaire thrombectomy with low-dose booster tirofiban injection. Neurointervention. 2016 sep;11(2):114-9. Doi: 10. 5469/neuroint. 2016. 11. 2. 114. Epub 2016 sep 3. Pmid: 27621948; pmcid: pmc5018547. 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.
 
Event Description
Literature article: goh dh, jin sc, jeong hw, ha sy. Mechanical solitaire thrombectomy with low-dose booster tirofiban injection. Neurointervention. 2016 sep;11(2):114-9. Doi: 10. 5469/neuroint. 2016. 11. 2. 114. Epub 2016 sep 3. Pmid: 27621948; pmcid: pmc5018547. Objective and methods: mechanical thrombectomy using a solitaire stent has been associated with a high recanalization rate and favorable clinical outcome in intra-arterial thrombolysis. To achieve a higher recanalization rate for mechanical solitaire thrombectomy, we used an intra-arterial low-dose booster tirofiban injection into the occluded segment after stent deployment. We report the safety and recanalization rates for mechanical solitaire thrombectomy with a low-dose booster tirofiban injection. Between february and march 2013, 13 consecutive patients underwent mechanical solitaire thrombectomy with low-dose booster tirofiban injection. The occlusion sites included the proximal middle cerebral artery (5 patients), the internal carotid artery , the top of the basilar artery and the distal middle cerebral artery. Six patients underwent bridge treatment, including intravenous tissue plasminogen activator. Tirofiban of was used in all patients except one. All occluded vessels were recanalized after 3 attempts at stent retrieval. Successful recanalization was achieved in all patients. Procedural complications developed in 3 patients. Mortality occurred in one patient with a basilar artery occlusion due to reperfusion brain swelling after mechanical solitaire thrombectomy with low-dose booster tirofiban injection. Favorable clinical outcome was observed in 8 patients. Our modified mechanical solitaire thrombectomy method using a low-dose booster tirofiban injection might enhance the recanalization rate with no additive hemorrhagic complications. Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: 6f envoy guiding catheter (codman, raynham, ma). Other cerenovus devices that were also used in this study: n/a. Non-cerenovus devices that were also used in this study: 6f shuttle catheter (cook medical inc. , bloomington, in), excelsior xt 27 microcatheter (stryker, fremont, california), synchro 0. 014 microwire (stryker, fremont, california), solitaire stent (ev3 inc. , irvine, california. Adverse event(s) and provided interventions: paitent 7 - 58/m - procedureal complications - subarachnoid hemorrhage, patient 8 - 49/f - procedureal complications - subarachnoid hemorrhage, patient 12 - 79/f - procedureal complications - hemorrhage transformation.
 
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Brand NameGUIDE CATHETER
Type of DevicePERCUTANEOUS CATHETER
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin-blanc 38
le locle CH240 0
SZ CH2400
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 Key12566236
MDR Text Key274922939
Report Number3008264254-2021-00023
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K000715
Number of Events Reported1
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 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKENVOY
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2021
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 Treatment Data
Date Received: 10/01/2021 Patient Sequence Number: 1
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