MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 6X20; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0620
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone and email address are not available / reported.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 6mm x 20cm orbit galaxy complex fill was received contained in the decontamination pouch.Visual inspection was performed.The hypotube was observed broken.A kink is observed near the broken area on the hypotube.The embolic coil was returned inside the introducer.Microscopic inspection was performed.Under magnification, the embolic coil was observed still attached to the delivery system without any damages observe on it (i.E., no elongations, no kinks, no non-concentric loops were noted).The issues regarding resistance felt during the advancement was confirmed based on the findings mentioned above.The broken and kinked condition appearance of the returned device suggests that it was subjected to excessive force to overcome the friction with the microcatheter.Factors not described in the event description, such as inadequate flush, may have contributed to the issue encountered during the procedure.According to the risk documentation, resistance in microcatheter is a potential issue that can occur during microcoil placement due to excessively tortuous anatomy, which can result in the hypo-tube being broken.There is no indication that the issue reported is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30862483) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) contains the following precautions: ¿ never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.¿ if friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.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 cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, 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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during an endovascular embolization, there was resistance while pushing the coil, a 6mm x 20cm orbit galaxy complex fill (640cf0620 / 30862483) into the microcatheter.The procedure was delayed by 5 minutes.It was successfully completed without any negative patient impact.On 14-mar-2024, additional information was received.Per the information, the procedure was targeting the internal carotid artery (ica).There was no remarkable anatomical / vessel characteristic such as calcification / tortuosity.The reported delay of 5 minutes was not considered to be clinically significant.The concomitant microcatheter used was a prowler select lpes (606s155x / 31178991).The microcatheter was not removed nor replaced.Other devices were successfully used with the microcatheter prior to the reported issue: 10mm x 30cm orbit galaxy, 9mm x 25cm orbit galaxy, and 7mm x 21cm orbit galaxy.The complaint device did not appear damage at any time; no damage was noted.Nothing was noted to be obstructing the microcatheter.A continuous flush was maintained through the microcatheter.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rotating hemostasis valve (rhv) during the device advancement.Based on the result of the product analysis completed on 16-apr-2024, the reported issue meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".

• Brand Name: OG TDL CMPLX FILL COIL 6X20
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 19121811
• Report Number: 3008114965-2024-00407
• Device Sequence Number: 20773422
• Product Code: KRD
• UDI-Device Identifier: 10886704030348
• UDI-Public: 10886704030348
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 640CF0620
• Device Lot Number: 30862483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SELECT LPES
• Patient Sex: Unknown