MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. UNK_SUCTION COAGULATOR

Catalog Number	004225
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via journal article title: direct tumoral puncture embolization of onyx before endoscopic endonasal resection of a massive juvenile angiofibroma for a patient with von willebrand disease ¿ a case report and review of literature author(s): laura-elisabeth gosselin, pierre-olivier champagne, pascale lavoie, sylvie nadeau.Citation: international journal of surgery case reports 120 (2024) 109784.The aim of this study is to demonstrate the safety and the usefulness of this embolization technique on a pediatric case of juvenile angiofibroma and to compare our results to previously reported cases.This is a case of a 12-year-old patient suffering from von willebrand disease presented with voluminous juvenile angiofibroma with intracranial extension.Internal carotid artery branches partially vascularized the tumor.The patient underwent surgical intervention with endonasal endoscopic approach.Surgical resection of the anterior tumoral section and a partial debulking of the right orbit was achieved with megadyne¿ succion coagulators (ethicon©).However, after a partial resection of the nasopharynx portion, an important tumoral bleeding compelled surgeons to stop the surgery.Total blood loss was 1 l.The patient stayed hemodynamically stable but received one transfusion postoperatively.A second surgical intervention took place a month later.Via an endonasal endoscopic approach, surgeons coagulated the tumor capsule with a competitor aquamantys ¿ bipolar system (manufacturer: medtronic).Small tumoral sections were resected but a significant bleeding promptly occurred, coming from the right posterior ethmoidal tumoral section.Total blood loss was 1.6 l.The patient remained hemodynamically stable but was given 2 transfusions during surgery.A different preoperative embolization technique was then performed, using an intra-tumoral direct puncture of a competitor onyx® to directly occlude tumoral feeding vessels, including internal carotid artery branches.No complication occurred.The procedure devascularized 90% of the tumor.3 days later, the patient underwent his third surgery.The naso-ethmoidal section was resected and extruded by the patient's mouth.Residual skull base tumor was then dissected.To prevent the onset of csf leak, a nasoseptal flap was used to seal the defect.Surgicel® (ethicon) and a competitor nasopore® (manufacturer: stryker) were used to temporarily obliterate the nasal cavity and to protect reconstruction.The follow-up to this date revealed no late complication and no residual symptoms.Reported complications included important tumoral bleeding which compelled surgeons to stop the surgery (n=1).In conclusion, direct intratumoral onyx embolization allowed complete resection of a massive juvenile angiofibroma, for a patient with von willebrand disease.Our data suggest that this technique is safe and may be instrumental for a juvenile angiofibroma¿s resection, even if little vascularization comes from internal carotid artery branches.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/12/2024.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK_SUCTION COAGULATOR
• Common Device Name: UNK_SUCTION COAGULATOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20912695
• Report Number: 1721194-2024-00098
• Device Sequence Number: 12880725
• Product Code: GEI
• UDI-Device Identifier: 10614559105153
• UDI-Public: 10614559105153
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 004225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Race: White