MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CEREPAK FREEFORM; CEREPAK FREEFORM XTRASOFT DETACHABLE COIL SYSTEM

Catalog Number	XCR123509
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization to the anterior communicating artery (acom), a freeform xsft 3.5mm x 9 cm coil (xcr123509, 31146355) was the third coil to be inserted, however did not detach after attempting once with a mechanical detachment handle (mdh1, 102109430) and manual detachment 4 times.The coil was removed without difficulty and a non j&j coil was placed, detached and case was then complete.Additional event information received on 25-oct-2024 indicated that two coils were previously implanted during procedure.There was ¿a little back and forth but after a couple of times, coil fit in aneurysm¿.There was some catheter backup or tip deflection, but it was minimal.There was no damage to the embolic coil or any device component.There was no vessel excessively tortuous or with acute bends.There was no patient injury reported.The procedure was prolonged about 10 minutes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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
Product complaint # (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint (b)(4).Updated sections on this med watch report: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion: as reported by the field, during a coil embolization to the anterior communicating artery (acom), a freeform xsft 3.5mm x 9 cm coil (xcr123509, 31146355) was the third coil to be inserted, however did not detach after attempting once with a mechanical detachment handle (mdh1, 102109430) and manual detachment 4 times.The coil was removed without difficulty and a non j&j coil was placed, detached and case was then complete.Additional event information received on 25-oct-2024 indicated that two coils were previously implanted during procedure.There was ¿a little back and forth but after a couple of times, coil fit in aneurysm¿.There was some catheter backup or tip deflection but it was minimal.There was no damage to the embolic coil or any device component.There was no vessel excessively tortuous or with acute bends.There was no patient injury reported.The procedure was prolonged about 10 minutes.A non-sterile freeform xsft 3.5mm x 9 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, and the proximal end of the puller-wire was exposed.The embolic coil was inspected under magnification, and a slight stretched condition was noted exposing the blue fiber.No damages were observed at the proximal key.No unintentional weld was noted on the loop hole.A manufacturing record evaluation was performed for the finished device 31146355 number, and no non-conformances related to the malfunction were identified.The issue reported regarding the failure to detach is confirmed based on the attached condition of the embolic coil to the delivery unit after activating the manual break.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.It should be noted that product failure is multifactorial.As the stretched condition of the embolic coil was not originally reported, this condition is considered to be the result of the post-handling of the device; therefore, it is not considered related to the failure reported.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 FREEFORM
• 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: 20632118
• Report Number: 3008114965-2024-01081
• Device Sequence Number: 7928836
• Product Code: KRD
• UDI-Device Identifier: 10886704083771
• UDI-Public: (01)10886704083771(17)260731(10)31146355
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/20/2024

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: XCR123509
• Device Lot Number: 31146355
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 12/20/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/17/2024; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: MECHANICAL DETACHMENT HANDLE.
• Patient Sex: Unknown