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 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 - procedural complications - subarachnoid hemorrhage, patient 12 - 79/f - procedural complications - hemorrhage transformation.

• Brand Name: GUIDE CATHETER
• Type of Device: PERCUTANEOUS 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 Key: 12566237
• MDR Text Key: 274918822
• Report Number: 3008264254-2021-00022
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K000715
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR