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	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone: (b)(6).Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (31103844) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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 a vascular procedure, the 95cm cerebase da guide sheath ((b)(6)) broke inside the patient.A leakage of contrast medium occurred at the fracture site.It was reported that other vessels that were not part of the target visualization were also visualized.The catheter was replaced.There was loss of contrast medium and time.The procedure was delayed; the duration of the delay was not reported.There was no report of any negative patient impact.On 31-jan-2024, additional information was received.Per the information, the intended procedure was an elective aneurysm treatment procedure.It was not an adapt (direct aspiration first pass technique) case; the device was not snaked (advanced without microwire / microcatheter).The vessel was not excessively tortuous nor with acute bends.The device did not fracture into two separate pieces; it was ¿only a tear without separation.¿ the replacement catheter was another cerebase ((b)(6)).The procedure was successfully completed with the new replacement catheter.There was a 5-minute delay that the physician did not deem clinically significant.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 07-mar-2024.The device underwent evaluation and analysis.The investigation finding is documented below.Investigation summary: the catheter was received with a partial fracture in the l8 segment, near the l8-l9 joint, but not involving the fuse joint itself.The other joints in the distal region of the catheter were intact, without obvious separations.Image 3 and image 4 show the fracture surface.Note that the surfaces show ductile tearing of the polymer topcoat, indicating the polymer elongated within the extruded section prior to failure and did not separate cleanly from an adjacent polymer segment, or ¿crack¿.There is no sign of material breakage on the inside radius of the kink.To assess how thoroughly the catheter layers were fused together, the catheter was sectioned transversely after which it was attempted to stretch the catheter segment l8 to failure.It was only possible to tear out a few wires at the edges of the section, but it demonstrated how well integrated the braid wires were and how securely bonded the polytetrafluoroethylene (ptfe) was to the polymer topcoat.Dimensional analysis: outer diameter (od) dimensions were taken at all segments and interfaces, as well as 3 points along the proximal shaft.All dimensions met the drawing specs of 0.106 inches ¿ 0.110 inches distally (tip ¿ l9) and 0.107 inches ¿ 0.111 inches (l10 and proximal shaft).Investigation conclusion: based on the visual inspection of the fracture zone which shows ductile elongation of the polymer topcoat prior to breakage, and the evidence of good topcoat flow and integration with the braid wires and ptfe, the part appears to have been fused properly.The shaft separation within the polymer section and not at a joint between segments also supports that the catheter was properly fused.The reason for the failure of the catheter is likely that it was kinked more rapidly than the polymer topcoat material could accommodate through stretching, causing a break.A review of manufacturing documentation associated with this lot (31103844) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No:(b)(4).The purpose of this mdr submission is to add the recall number for the 95cm cerebase da guide sheath (gs9095sd) from lot 31103844.Section h.9: fda correction/ removal reporting no.: 3007628272-02/02/2024-001-r.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.

• 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: 18616690
• Report Number: 3008114965-2024-00102
• Device Sequence Number: 2406751
• Product Code: QJP
• UDI-Device Identifier: 10886704082323
• UDI-Public: 10886704082323
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2024

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: 08/31/2025
• Device Catalogue Number: GS9095SD
• Device Lot Number: 31103844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 01/29/2024; 03/07/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/21/2024; 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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
• Patient Age: 40 YR
• Patient Sex: Male