MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASH 14 CERE 3MMX4.0CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CRC140304-30
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization of the inferior cerebellar artery (ica), the physician decided to pull out a cash 14 cere coil 3mmx4.0cm (crc14030430, s14375) because it¿s size was not appropriate with aneurysm.During resheathing of the coil, it was failed to be re-zipped.There was no surgery delayed due to the reported event.The procedure was successfully completed.Additional information received indicated that an adequate continuous flush was maintained through the unspecified microcatheter (mc).The delivery wire was not protruding from the introducer.There was no damage noted to the sheath introducer.There was no split.There was no resistance at any time during advancement of the coil through the mc.It was not necessary to remove the microcatheter.No additional intervention was required.There was no blood flow restriction/reduction as a result of the event.Based on the analysis of the device received, the embolic coil is stretched.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was noted as being stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Complaint conclusion: as reported by the field, during a coil embolization of the inferior cerebellar artery (ica), the physician decided to pull out a cash 14 cere coil 3mmx4.0cm (crc14030430, s14375) because it¿s size was not appropriate with aneurysm.During resheathing of the coil, it was failed to be re-zipped.There was no surgery delayed due to the reported event.The procedure was successfully completed.Additional information received indicated that an adequate continuous flush was maintained through the unspecified microcatheter (mc).The delivery wire was not protruding from the introducer.There was no damage noted to the sheath introducer.There was no split.There was no resistance at any time during advancement of the coil through the mc.It was not necessary to remove the microcatheter.No additional intervention was required.There was no blood flow restriction/reduction as a result of the event.A non-sterile unit cash 14 cere 3mmx4.0cm was received inside of a pouch.The device was visually inspected, and it was found that dpu is protruded from introducer, no other damages or anomalies were observed.A microscopic inspection was performed, and it was found that the embolic coil is stretched and protruded from the introducer.The functional test could not be performed due to the conditions in which the device was received.A manufacturing record evaluation (mre) was performed for the finished device s14375 number, and no non-conformance was found during the review.Cerenovus conducted a visual and microscopic inspection.The functional test could not be performed due to the conditions in which the device was returned for evaluation.During the visual analysis of the device, it was noted that the dpu is protruded from the introducer, no other damages or anomalies were observed, when the coil was inspected under microscopic magnification, it was found stretched and protruded from the introducer.The coil could have been stretched during the removal from the microcatheter; while trying to advance a stretched coil, it starts to ravel and it subsequently can cause the dpu protrusion, as observed on the returned device.Considering the factors described above, the customer complaint regarding rezipping difficulty was confirmed.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.Zipping difficulty -rezipping is a known potential issue associated with the use of this device.It should be noted that product failure is multifactorial.The instructions for use (ifu) do contain the following recommendations: ¿ do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.¿ if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.After flushing, reinsert the introducer into the infusion catheter hub as described in ¿microcoil placement¿ section above.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.An embolic coil becomes stretched when an excessive pull force is applied to the device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• Brand Name: CASH 14 CERE 3MMX4.0CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12778139
• Report Number: 3008114965-2021-00562
• Device Sequence Number: 11689400
• Product Code: HCG
• UDI-Device Identifier: 00878528004424
• UDI-Public: 00878528004424
• Combination Product (Y/N): N
• PMA/510(K) Number: K072173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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: 05/31/2022
• Device Model Number: CRC140304-30
• Device Catalogue Number: CRC14030430
• Device Lot Number: S14375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2017
• 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: UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown