MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM 4MM X 12 CM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	SCR120412
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Section d.2b: procode is krd/hcg.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 (31140706) 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: 3008114965-2023-00965, 3008114965-2023-00966, and 3008114965-2023-00967.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 the physician was embolizing a carotid-cavernous fistula (ccf) with moderate tortuosity.The physician deployed a total of 12 coils ad then used onyx¿ 34 liquid embolic and onyx¿ 18 liquid embolic (medtronic).The following three coils: 5mm x 10cm cerepak freeform xsft (xcr120510 / 31146337), 5mm x 15cm cerepak freeform xsft (xcr120515 / 31173107), and 4mm x 12cm cerepak freeform (scr120412 / 31140706) did not detach utilizing the manual detachment.It was reported that breaking of the manual break was difficult, but ultimately it was able to expose the pull wire and pull back the wire to attempt to detach the coil.The difficulty with the breaking of the manual break at the sorting happened on all coils documented in this complaint.All three coils were able to be removed without any negative patient impact.One of the coils reportedly detached on the table after removal.The reported issue resulted in minimal delay.There was no negative patient impact.
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 (b)(6) 2024.The investigation was completed on (b)(6) 2024.The investigation finding is documented below.Investigation summary: a non-sterile 4mm x 12cm cerepak freeform was received contained in the decontamination pouch.Visual inspection was performed.The embolic coil was observed detached from the delivery unit.The inner tube was not returned for evaluation.No deformities nor defects were noted on the detachment tube nor the loop wire.No contamination was noted at the distal end.The pull wire broke at the edge of the manual break.The pull-wire was slightly translated.The manual break was attempted; however, the damaged condition on the proximal end near the edge of the manual break indicates that the manual break was attempted at the wrong location.The pull-wire was attempted to be removed from the delivery system using a pull test, and the force to translate the wire reached 125 gram-force (gf).The wire could not be extracted from the peek by pulling through the fused assembly.The peek tube was dissected from the distal and proximal end, and no evidence of glue or pebax reflow was found on the distal end.The inner diameters (id) of the distal and proximal peek were measured and found within specifications.Dried blood residues were accumulated near the kinked featured on the pull-wire, increasing the difficulty to extract it.A review of manufacturing documentation associated with this lot (31140706) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.The issue reported regarding the difficulty to break the manual break was confirmed based on the attempts to detach the embolic coil, and the broken condition of the pull-wire.With the limited information available and the evidence obtained from the device inspection, there is no clear insight into the root cause and/or exact contributing factors that may have resulted in the observed failure mode.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damage from leaving the facility.It should be noted that product failure is multifactorial.The instructions for use (ifu) provides the following recommendations for the manual break use: 1.Locate the manual break indicator (mbi) markers approximately 20cm from the proximal end of the device.2.Using your thumb & forefinger, grip the delivery pusher with one hand precisely at the center of each of the mbi markers.3.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.4.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.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00965, 3008114965-2023-00966, and 3008114965-2023-00967.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: FREEFORM 4MM X 12 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: 18432785
• Report Number: 3008114965-2023-00967
• Device Sequence Number: 20724763
• Product Code: KRD
• UDI-Device Identifier: 10886704083139
• UDI-Public: 10886704083139
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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: 07/31/2026
• Device Catalogue Number: SCR120412
• Device Lot Number: 31140706
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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: FREEFORM XSFT 5MM X 10 CM.; FREEFORM XSFT 5MM X 15 CM.; ONYX¿ 18 LIQUID EMBOLIC (MEDTRONIC).; ONYX¿ 34 LIQUID EMBOLIC (MEDTRONIC).
• Patient Sex: Unknown