MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM MINI 1.5MM X 4CM; CEREPAK FREEFORM MINI DETACHABLE COIL SYSTEM

Catalog Number	MCR091540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
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 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.
Event or Problem Description
As reported by the field, during a coil embolization to the middle meningeal artery (mma), the physician was coiling left main trunk of mma.A heliform xsft xl 2mm x 8 cm coil was placed.Then the user asked for a second heliform xsft xl 2mm x 8 cm coil (xhe120208, 31118010).As the experienced technologist was advancing this coil through the introducer sheath, when she reached the fracture point of the manual break, the manual break fractured.There was no excessive force, everything was moving smoothly.It was not her first time using the product.Removed this coil from the microcatheter system and reopened another coil and successfully placed two more coils on the left side.On the right side he also wanted to coil the right main trunk of the mma.He placed 2 avenir coils successfully.Then as the technologist was advancing a freeform mini 1.5mm x 4cm coil (mcr091540, 31136066) through the introducer sheath, at the fracture point of the manual break, it again broke.Again, it was noted she was advancing smoothly and softly- no force was observed.Removed coil from microcatheter system, and a new 1.5x4 mini was successfully placed.The microcatheters used for both of these instances was a pnovus 17 from phenox.(a new one was obtained for the right side after liquid embolics were used).Additional information received on 22-jul-2024 indicated that there was no excessive tortuosity, no acute bends on either side.There was no aneurysm, they were sacrificing the medial meningeal artery.No difficulty positioning.There were no attempts made in using the detachment handle.There was no damage to the embolic coil or any device component.There was no patient injury.There were no procedural delays due to the event.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this med watch: b4, d4 (primary udi number), g3, g6, h2, h3, h6 and h11.Corrected data: d4 (primary udi number) complaint conclusion: as reported by the field, during a coil embolization to the middle meningeal artery (mma), the physician was coiling left main trunk of mma.A heliform xsft xl 2mm x 8 cm coil was placed.Then the user asked for a second heliform xsft xl 2mm x 8 cm coil (xhe120208, 31118010).As the experienced technologist was advancing this coil through the introducer sheath, when she reached the fracture point of the manual break, the manual break fractured.There was no excessive force, everything was moving smoothly.It was not her first time using the product.Removed this coil from the microcatheter system and reopened another coil and successfully placed two more coils on the left side.On the right side he also wanted to coil the right main trunk of the mma.He placed 2 avenir coils successfully.Then as the technologist was advancing a freeform mini 1.5mm x 4cm coil (mcr091540, 31136066) through the introducer sheath, at the fracture point of the manual break, it again broke.Again, it was noted she was advancing smoothly and softly- no force was observed.Removed coil from microcatheter system, and a new 1.5x4 mini was successfully placed.The microcatheters used for both of these instances was a pnovus 17 from phenox.(a new one was obtained for the right side after liquid embolics were used).Additional information received on 22-jul-2024 indicated that there was no excessive tortuosity, no acute bends on either side.There was no aneurysm, they were sacrificing the medial meningeal artery.No difficulty positioning.There were no attempts made in using the detachment handle.There was no damage to the embolic coil or any device component.There was no patient injury.There were no procedural delays due to the event.A non-sterile freeform mini 1.5mm x 4cm was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the manual break was found broken, as described in the event.The embolic coil was still attached to the delivery unit.No appearance of damages were observed.The embolic coil was inspected under magnification, and no damaged were found.No damages were noted at the proximal key.No unintentional weld was noted on the loop-hole.No contamination was noted at the distal end.A manufacturing record evaluation was performed for the finished device 31136066 number, and no non-conformances related to the malfunction were identified.The issue reported regarding the manual break prematurely breaking was confirmed based on the findings mentioned above.It is suggested that excessive force could had been inadvertently applied while advancing the embolic coil resulting in breaking the manual break prematurely; however, this remains speculative.According to risk documentation, an accidental mechanical product damage is a potential failure mode that can potentially degrade the device's performance.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 part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages from leaving the facility.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 caution: ¿ do not apply a tortuous bent to the area of the manual break markers.This will cause the delivery system to break.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this med watch: b4, b5, d4, 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.

• Brand Name: FREEFORM MINI 1.5MM X 4CM
• Common Device Name: CEREPAK FREEFORM MINI 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: 19893257
• Report Number: 3008114965-2024-00764
• Device Sequence Number: 20780394
• Product Code: KRD
• UDI-Device Identifier: 10886704082989
• UDI-Public: (01)10886704082989(17)260731(10)31136066
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2024

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: MCR091540
• Device Lot Number: 31136066
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 08/12/2024; 09/11/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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: PNOVUS¿ MICROCATHETER (WALLABY-PHENOX).
• Patient Sex: Unknown