MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNIFORM 7MM X 13.9 CM; CEREPAK UNIFORM DETACHABLE COIL SYSTEM

Catalog Number	FCX100713
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
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 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.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 company is seeking this information through the event investigation.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 four products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00435, 3008114965-2024-00436, and 3008114965-2024-00438.
Event or Problem Description
As reported by the field, this was a coil embolization to a left anterior communicating artery aneurysm (acomm) with high tortuosity.The physician attempted to coil aneurysm initially with only coils.First coil was a uniform 7mm x 30 cm (fcx100730, 31127140).This specific aneurysm had a ledge towards the neck of the aneurysm that caused a headway duo 156cm microcatheter (mc) to become unstable.Because of the ledge, because of the force needed to advance the coil into the aneurysm, the coil fractured at the junction of the coil and the pusher wire.The 5 fr sofia was advanced and the coil was taken out with the microcatheter as a unit.The entire coil was removed.New microcatheter was used to re-access the aneurysm.The second coil, a uniform 7mm x 13.9 cm (fcx100713, 31098464) was advanced into the aneurysm without any issue.Attempted to detach coil with mechanical detachment handle (mdh1, 102109430) unsuccessfully.The manual break was used correctly and that was unsuccessful as well.That coil was removed without any issues.A micrusphere xl 7mmx14cm coil (ssr10071420, 30529251) was used at this point with the same microcatheter in place.That coil fractured as well due to the ledge of the aneurysm as described before.That coil was removed as a system also with the same technique used for the first coil.Balt coils were used for the rest of this case without any issues.The fracturing of these coils did cause delay in case about 30 minutes.No negative impact to patient was reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this med watch: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion: as reported by the field, this was a coil embolization to a left anterior communicating artery aneurysm (acomm) with high tortuosity.The physician attempted to coil aneurysm initially with only coils.First coil was a uniform 7mm x 30 cm (fcx100730, 31127140).This specific aneurysm had a ledge towards the neck of the aneurysm that caused a headway duo 156cm microcatheter (mc) to become unstable.Because of the ledge and the force needed to advance the coil into the aneurysm, the coil fractured at the junction of the coil and the pusher wire.The 5 fr sofia was advanced and the coil was taken out with the microcatheter as a unit.The entire coil was removed.New microcatheter was used to re-access the aneurysm.The second coil, a uniform 7mm x 13.9 cm (fcx100713, 31098464) was advanced into the aneurysm without any issue.Attempted to detach coil with mechanical detachment handle (mdh1, 102109430) unsuccessfully.The manual break was used correctly and that was unsuccessful as well.That coil was removed without any issues.A micrusphere xl 7mmx14cm coil (ssr10071420, 30529251) was used at this point with the same microcatheter in place.That coil fractured as well due to the ledge of the aneurysm as described before.That coil was removed as a system also with the same technique used for the first coil.Balt coils were used for the rest of this case without any issues.The fracturing of these coils did cause delay in case about 30 minutes.No negative impact to patient was reported.The device was not returned; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31098464 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are procedural factors that may have contributed to the reported failure.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.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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: UNIFORM 7MM X 13.9 CM
• Common Device Name: CEREPAK UNIFORM 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: 19197088
• Report Number: 3008114965-2024-00437
• Device Sequence Number: 7616762
• Product Code: KRD
• UDI-Device Identifier: 10886704084068
• UDI-Public: 10886704084068
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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: 05/31/2026
• Device Catalogue Number: FCX100713
• Device Lot Number: 31098464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2023
• 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