MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GS 90, 95 CM, STRAIGHT, DISTAL; CATHETER, PERCUTANEOUS

Catalog Number	GS9095SD
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier and age were not provided.Section e.1: the initial reporter phone: (b)(6).Section h.9: fda correction/ removal reporting no.: 3007628272-02/02/2024-001-r.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (31154812) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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 the procedure, the 95cm cerebase da guide sheath (gs9095sd / 31154812) broke.There was no patient harm nor significant delay reported.On 13-feb-2024, additional information was received.Per the information, the procedure was a cerebral thrombectomy targeting the left m1 segment of the middle cerebral artery (mca).The vessel was excessively tortuous with acute bends.This was not an adapt (direct aspiration first pass technique) case; the device was not snaked (advanced without wire / microcatheter).The cerebase did not become fractured into two separate pieces.The device was not replaced.The procedure was successfully completed.The information indicated that the concomitant embovac large bore catheter had ¿severe lengthening and deformation of the embovac during the retrieval maneuver due to kinking of the cerebase guiding catheter.¿ a continuous flush was maintained through the procedure.

• Brand Name: GS 90, 95 CM, STRAIGHT, DISTAL
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 18744745
• Report Number: 3008114965-2024-00212
• Device Sequence Number: 12361307
• Product Code: QJP
• UDI-Device Identifier: 10886704082323
• UDI-Public: 10886704082323
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192804
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/20/2024

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: 11/30/2025
• Device Catalogue Number: GS9095SD
• Device Lot Number: 31154812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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: IC 71, 132 CM, CE, ASP. IND.
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White