MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNIFORM XL 7MM X 14.3 CM; CEREPAK UNIFORM XL DETACHABLE COIL SYSTEM

Catalog Number	FCX180714
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, this was a very tortuous pipeline/coiling case of the left distal internal carotid artery (ica) over a 9mm in size, neck measuring almost 8mm.A pipeline embolization device was deployed.A headway duo 156cm microcatheterwas jailed into the aneurysm prior to the deployment of the pipeline.The first of the uniform xl 7mm x 14.3 cm coil ((b)(6)) was advanced through the microcatheter (mc) with minimal resistance around the second manual break marker.The coil was inserted into the aneurysm without difficulty.The manual break technique was attempted without success.As the doctor attempted to then pull the coil out of the aneurysm, the coil seemed to prematurely detach in the microcatheter.He was able to push the coil back into the aneurysm.The rest of the case was coiled with the dp2-3 cashmeere coils without any issue.No negative patient outcome and minimal delay of treatment.
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 remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31173115 number, and no non-conformances related to the malfunction were identified.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received on 20-dec-2023 indicated that three coils were previously implanted during procedure.There was no positioning difficulty in the aneurysm.No attempts were made using the detachment handle.The manual detachment would not break.The event did not delay the procedure.Complaint conclusion: as reported by the field, this was a very tortuous pipeline/coiling case of the left distal internal carotid artery (ica) over a 9mm in size, neck measuring almost 8mm.A pipeline embolization device was deployed.A headway duo 156cm microcatheter was jailed into the aneurysm prior to the deployment of the pipeline.The first of the uniform xl 7mm x 14.3 cm coil (fcx180714, 31173115) was advanced through the microcatheter (mc) with minimal resistance around the second manual break marker.The coil was inserted into the aneurysm without difficulty.The manual break technique was attempted without success.As the doctor attempted to then pull the coil out of the aneurysm, the coil seemed to prematurely detach in the microcatheter.He was able to push the coil back into the aneurysm.The rest of the case was coiled with the dp2-3 cashmeere coils without any issue.No negative patient outcome and minimal delay of treatment.Additional information received on 20-dec-2023 indicated that three coils were previously implanted during procedure.There was no positioning difficulty in the aneurysm.No attempts were made using the detachment handle.The manual detachment would not break.The event did not delay the procedure.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31173115 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 circumstances of the procedure that may have contributed to the reported failure.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.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 XL 7MM X 14.3 CM
• Common Device Name: CEREPAK UNIFORM 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: 18327626
• Report Number: 3008114965-2023-00956
• Device Sequence Number: 7438467
• Product Code: KRD
• UDI-Device Identifier: 10886704084488
• UDI-Public: 10886704084488
• 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
• Device Implanted Year: 2023
• 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): 01/09/2024

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: 09/30/2026
• Device Catalogue Number: FCX180714
• Device Lot Number: 31173115
• 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: 12/02/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2023
• 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: HEADWAY DUO 156CM MICROCATHETER; PIPELINE EMBOLIZATION DEVICE
• Patient Sex: Unknown