MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CEREPAK HELIFORM; CEREPAK HELIFORM XL DETACHABLE COIL SYSTEM

Catalog Number	SHD180312
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization to the middle cerebral artery (mca) bifurcation, a heliform xl 3mm x 12 cm coil (shd180312, 31168339) did not detach with the mechanical detachment handle (mdh1, unknown lot), it also did not detach manually.The doctor retrieved the coil with no problems.The surgery was not delayed due to the reported event.The procedure was successfully completed.Additional event information received on 26-feb-2025 indicated that three coils were previously implanted during procedure.There was no resistance during advancement of the device through the microcatheter or positioning difficulty in the aneurysm.Three attempts were made with the detachment handle.It was noted that the pull wire of the device was stretched.There vessel was not excessively tortuous or with acute bends.Additional event information received on 27-feb-2025 confirmed that the coil was stretched.
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.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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.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.
Additional Manufacturer Narrative
Manufacturer's ref.No: (b)(4).Complaint conclusion: as reported by the field, during a coil embolization to the middle cerebral artery (mca) bifurcation, a heliform xl 3mm x 12 cm coil (shd180312, 31168339) did not detach with the mechanical detachment handle (mdh1, unknown lot), it also did not detach manually.The doctor retrieved the coil with no problems.The surgery was not delayed due to the reported event.The procedure was successfully completed.Additional event information received on 26-feb-2025 indicated that three coils were previously implanted during procedure.There was no resistance during advancement of the device through the microcatheter or positioning difficulty in the aneurysm.Three attempts were made with the detachment handle.It was noted that the pull wire of the device was stretched.There vessel was not excessively tortuous or with acute bends.A non-sterile heliform xl 3mm x 12 cm coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the embolic coil was still attached to the delivery unit.The manual break was attempted at the proper location.A kinked condition was found at the distal end of the main delivery tube.No other damages were found.Microscopic inspection was performed on the embolic coil.It was observed to be in good condition; there was no structural damage (i.E., no stretched conditions, no kinks).No damages were noted at the proximal key.No unintentional weld was noted on the loop-hole.A manufacturing record evaluation was performed for the finished device 31168339 number, and no non-conformance's related to the malfunction were identified.Although the kinked condition on the main delivery tube was not originally reported, according to risk documentation, accidental mechanical product damage is a potential failure mode that can result in potential degradation of device performance.Therefore, the issue reported regarding the failure to detach the embolic coil is confirmed.There is no indication that the issues reported in the complaint result from a defect inherently related to the cerepak device.The stretched conditions is not confirmed, as no damages on the embolic coil nor the pull wire were encountered.As part of j&j medtech 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.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.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: CEREPAK HELIFORM
• Common Device Name: CEREPAK HELIFORM XL 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: 21561235
• Report Number: 3008114965-2025-00203
• Device Sequence Number: 4430451
• Product Code: KRD
• UDI-Device Identifier: 10886704083467
• UDI-Public: (01)10886704083467(17)260930(10)31168339
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: SHD180312
• Device Lot Number: 31168339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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 Sex: Unknown