MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM XSFT 3MM X 4 CM; CEREPAK FREEFORM XTRASOFT DETACHABLE COIL SYSTEM

Catalog Number	XCR120304
Medical Device Problem Code	Separation Failure (2547)
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
Product complaint (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg section d4 - the product lot number is not available / not reported.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.This is one of six products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00167, 3008114965-2024-00168, 3008114965-2024-00169, 3008114965-2024-00171 and 3008114965-2024-00172.
Event or Problem Description
As reported by the field, during a coil embolization to the anterior communicating artery (accom), two freeform xsft 4mm x 8 cm coils (xcr120408, 31126838), a freeform xsft 3mm x 6 cm coil (xcr120306, 31136147) and a two freeform xsft 3mm x 4 cm coils (xcr120304, lot unknow) and (xcr120304, 31131259) were advanced into aneurysm and manual detachment was attempted with no success.The coils were removed from the patient.The freeform xsft 3mm x 4 cm coils were placed into the aneurysm and detachment was attempted with a mechanical detachment handle (mdh1) with no success.The coils were removed from the patient.Additional event information was received on 22-jan-2024 indicated that a stryker sl-10 microcatheter was used.Three coils were successfully detached with manual detachment prior to the failure, then two failures with 4mm x 8 cm coil, then a successful detachment of two 3mm x 6 cm, then a failed 3mm x 6 cm , then two more failed with 3mm x 4 cm with detachment handle.There was no resistance during advancement of the device through the microcatheter or positioning difficulty in the aneurysm.There was no damage to the embolic coils or any device component.There was mild tortuosity.The event did not result in any injury to the patient.There were a few minutes of procedural delay due to the event.The physician stopped procedure and did not want to continue.Aneurysm was almost packed, and he would follow the patient in a few months to evaluate.
Additional Manufacturer Narrative
Product complaint # (b)(4) section b5: additional event information was received on 06-mar-2024 indicating that the account had several failures over the course of two weeks and felt it warranted a submission.Speaking with the physician he felt having a bend proximal in the system contributed to the failure.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Complaint conclusion: as reported by the field, during a coil embolization to the anterior communicating artery (accom), two freeform xsft 4mm x 8 cm coils (xcr120408, 31126838), a freeform xsft 3mm x 6 cm coil (xcr120306, 31136147), and a two freeform xsft 3mm x 4 cm coils (xcr120304, lot unknown) and (xcr120304, 31131259) were advanced into aneurysm and manual detachment was attempted with no success.The coils were removed from the patient.The freeform xsft 3mm x 4 cm coils were placed into the aneurysm and detachment was attempted with a mechanical detachment handle (mdh1) with no success.Additional event information was received on 22-jan-2024 indicating that a stryker sl-10 microcatheter (mc) was used.Three coils were successfully detached with manual detachment prior to the failure, then two failures with 4mm x 8 cm coil, then a successful detachment of two 3mm x 6 cm, then a failed 3mm x 6 cm , then two more failed with 3mm x 4 cm with detachment handle.There was no resistance during advancement of the device through the microcatheter or positioning difficulty in the aneurysm.There was no damage to the embolic coils or any device component.There was mild tortuosity.The event did not result in any injury to the patient.There were a few minutes of procedural delay due to the event.The physician stopped procedure and did not want to continue.Aneurysm was almost packed, and he would follow the patient in a few months to evaluate.A non-sterile freeform xsft 3mm x 4 cm coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the embolic coil was found detached from the delivery system.The detachment tube was stretched.No visible defects were noted on the loop wire, and no contamination was found on the distal end.The pull-wire broke at 12cm, and it was translated.The manual break was attempted at the proper location.The pull-wire was attempted to be extracted from the fused assembly, and it was difficult as a film of dried blood was found inside the lumen around the pull-wire.Dried blood residues were found inside the peek lumen as well.The ablation pattern was inspected and found acceptable.The outer diameters (od) of the pull-wire were measured, and found to be 0.001862 inches at the ablated area and 0.00221 inches at the ptfe area.No visual defects were noted, nor evidence of ptfe delamination or unintentional weld.The peek tube was dissected from the distal and proximal ends, no evidence of glue or pebax reflow was noted on the distal end of the peek tube.The peek inner diameters were measured at the distal and proximal ends, and found within specifications.The welding location was visually inspected for correct welding/gluing, and it was found acceptable.The wire broke at 11.5 cm with respect to the welding location.The crimp of the inner and outer tubes was inspected.The exposed length of the inner tube was 5.2 cm, and it was not deformed.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.The issue reported regarding the failure to detach the embolic coil could not be evaluated since the embolic coil was not attached to the delivery system.With the limited information available, a conclusive cause cannot be determined; however, factors not described within the information available such as device manipulation 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.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: 1.Remove the detacher from the protective packaging and place it within the sterile field.The detacher is packaged separately for single patient use only.2.Confirm again under fluoroscopy that the coil alignment marker of the delivery tube creates a ¿t¿ with the proximal marker of the microcatheter.3.Verify that the rhv is firmly locked around the delivery tube to ensure that the coil does not move during connection process.Ensure the delivery tube is straight between the rhv and the detacher.4.Hold the delivery tube approximately 3 inches from proximal end and bring the detacher over the delivery tube until a firm stop is felt.5.Maintain the delivery tube position within the detacher and use a thumb to pull back the slider on the detacher.6.Continue to pull on the slider until end of travel or a click is heard.Gently release the slider until it returns to starting position or a second click is heard.Remove detacher by slowly withdrawing it from the delivery tube.Note: detacher must remain in sterile field until the procedure is completed.7.Fluoroscopically verify that the coil is detached by gently pulling back the delivery tube approximately 1cm.If the coil has detached, remove the delivery tube from the microcatheter.8.If the coil has not detached, repeat steps 3-7.If 2 unsuccessful detachments occur, discard the detacher and proceed to the manual break section.9.Repeat steps 1-8 until the procedure is completed.Discard the detacher.Caution: always perform fluoroscopic verification of detachment prior to withdrawing the delivery system fully.Failure to do so may lead to an embolic complication.10.After detaching the coil, remove the delivery tube from the microcatheter and discard.11.Repeat the above sequence for all additional coils until the procedure is complete.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: FREEFORM XSFT 3MM X 4 CM
• Common Device Name: CEREPAK FREEFORM XTRASOFT DETACHABLE COIL SYSTEM
• 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 ; 3035526892
• MDR Report Key: 18625679
• Report Number: 3008114965-2024-00170
• Device Sequence Number: 18073877
• Product Code: KRD
• UDI-Device Identifier: 10886704083634
• UDI-Public: 10886704083634
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2024

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 Catalogue Number: XCR120304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/14/2024; 03/06/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/14/2024; 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 3MM X 6 CM.; FREEFORM XSFT 4MM X 8 CM.; MECHANICAL DETACHMENT HANDLE.; STRYKER SL-10 MICROCATHETER.
• Patient Sex: Unknown