MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNIFORM XL 18MM X 46 CM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	FCX181846
Medical Device Problem Codes	Material Separation (1562); Separation Failure (2547); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a pipeline / coil embolization case in targeting a right distal internal carotid artery (ica) aneurysm over 2cm in size with a neck measured at almost 20mm in a very tortuous vasculature, after many attempts with multiple wires and catheters, access was obtained into the right middle cerebral artery (mca) and a 5mm x 35mm pipeline embolization device (ped) (medtronic) was deployed.A headway® duo 156 microcatheter (microvention) was jailed into the aneurysm prior to the deployment of the ped.The first 18mm x 46cm cerepak uniform xl coil (fcx181846 / 31168338) was advanced through the microcatheter minimal resistance around the second manual break marker.The coil was inserted into the aneurysm without difficult.The manual break technique was attempted without success.The wire had fractured and the physician attempted to remove the wire with a forceps; the physician also attempt to retract the expose wire without success.The coil was then removed without issue and was found intact in the field.A second 18mm x 46cm cerepak uniform xl coil from the same lot (31168338) was advanced without any issue.A cerepaktm detacher (mdh1 / 102109430) was used to detach the second coil.The handle was used properly without success.The second coil was removed without issue.The manual detachment approach was attempted without success.The rest of the case was coiled with presidio and micrusphere coils without issue.There was minimal delay of treatment and no negative patient outcome reported.
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 email address is not available / reported.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 (31168338) 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 is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are 3008114965-2023-00911, and 3008114965-2023-00912.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 20-dec-2023.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00910, 3008114965-2023-00911, and 3008114965-2023-00912.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 report the investigational finding of the returned device.The complaint product was returned and received at cerenovus ¿ blue lagoon site for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 18mm x 46cm cerepak uniform xl coil was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the embolic coil was not attached to the delivery system and was not returned for evaluation.No deformities were noted on the detachment tube.No defects were noted on the loop wire, and no contamination was noted at the distal end.The pull wire was found broken at the edge of the main delivery tube near the manual break, and slightly translated.The manual break was attempted; however, the broken condition near the edge of the black marker and the evidence of the flattened condition of the main delivery tube suggests that the break was not clean.The pull wire was removed from the delivery system using an instron tester, and the detachment force reached 242 gram-force (gf) to translate the wire.The kink feature was inspected for location and dimensions; however, it got damaged during the extraction.The outer diameter (od) of the pull wire was measured and found to be 0.00178 inches at the ablated area, and 0.0022 inches at the ptfe area.No visual defects nor evidence of polytetrafluoroethylene (ptfe) delamination or unintentional weld were noted.Contamination (dried blood residues) were found in the peek lumen at multiple locations.The peek tube was dissected from the distal and proximal end.No evidence of glue or pebax reflow was found on the distal end of the peek tube.The inner diameters (id) of the distal and proximal ends were measured and found within specifications.A review of manufacturing documentation associated with this lot (31168338) 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.Although the returned conditions of the device and the lack of the embolic coil returned prevented the evaluation of the issue reported regarding the slight resistance felt while using the device, the issues reported regarding the failure to detach the embolic coil using the manual break, and the broken condition of the wire were confirmed based on the broken condition of the main delivery tube showing signs of failed attempts to manually break.According to the risk documentation, the inability to manually break the delivery system between the two manual break markers is a potential issue that can occur during the use of the manual break to detach the embolic coil.With the limited information available, a conclusive cause cannot be determined; however, factors not described within the information available such as device manipulation, operator's technique, anatomical tortuosity, etc., may have contributed to the issue encountered.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.It should be noted that product failure is multifactorial.The instructions for use (ifu) provides the following recommendations: locate the manual break indicator (mbi) markers approximately 20cm from the proximal end of the device.Using your thumb & forefinger, grip the delivery pusher with one hand precisely at the center of each of the mbi markers.Bend the proximal end of the pusher between the mbi markers approximately 90 degrees or until the tube snaps.If needed, continue bending and straightening until the tube separates and exposes the internal pull-wire.Ensure the proximal portion of the delivery tube is in line with the remaining tube.While holding the distal end, pull the proximal end approximately 2-3cm to release the coil.Note: if it is determined that the coil will not be detached, remove it from the microcatheter as outlined in the following section.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 is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00910, 3008114965-2023-00911, and 3008114965-2023-00912.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: UNIFORM XL 18MM X 46 CM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS, INC.; calle circuito int norte 1820; parque industrial salvacar; juarez 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 18315585
• Report Number: 3008114965-2023-00910
• Device Sequence Number: 6278202
• Product Code: KRD
• UDI-Device Identifier: 10886704084440
• UDI-Public: 10886704084440
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K220040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2024

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: 09/30/2026
• Device Catalogue Number: FCX181846
• Device Lot Number: 31168338
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 01/25/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/04/2024; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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: HEADWAY® DUO 156 MICROCATHETER (MICROVENTION); PIPELINE EMBOLIZATION DEVICE (MEDTRONIC)
• Patient Sex: Unknown