MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3.5X7.5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX3575
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, the detachment hub of an orbit galaxy xtrasoft coil (640cx3575, 30436668) was impacted.That part seemed damaged and decided to use a new product.The physician used same-like product and the procedure was successfully done.Additional information received indicated that there was a connection malfunction between the hub of the coil and the luer.According to the user, the coil hub and luer didn¿t fit perfectly for coil detachment and saline seemed to leak as well.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.This information was not provided in the reported event or available at the time of report submission.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.
Additional Manufacturer Narrative
Product complaint #(b)(4).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).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, the detachment hub of an orbit galaxy xtrasoft coil (640cx3575, 30436668) was impacted.That part seemed damaged and decided to use a new product.The physician used same-like product and the procedure was successfully done.Additional information received indicated that there was a connection malfunction between the hub of the coil and the luer.According to the user, the coil hub and luer didn¿t fit perfectly for coil detachment and saline seemed to leak as well.A non-sterile og cmplx xtra soft coil 3.5x7.Was received inside of a pouch.The hypotube presented bents at multiple locations (28 inches, 30 inches, 42 inches, and 47 inches from the proximal end).No further apparent damages were noted.The device was inspected under microscope, and the embolic coil was found in good normal conditions, still attached to the delivery unit with no evidence of heat applied to the rh.The luer activated valve (lav) was found to be cracked.A manufacturing record evaluation was performed for the finished device 30436668 number, and no non-conformances related to the malfunction were identified.The product was returned to cerenovus for evaluation.Visual inspection of the returned og cmplx xtra soft coil 3.5x7.5 revealed that the hypotube had multiple bents at 28 inches, 30 inches, 42 inches, and 47 inches from the proximal end.No further apparent damages were noted.Under microscopic magnification, the embolic coil was observed in good normal conditions, no kinks, elongations, or non-concentric loops were observed, and it was still attached to the delivery system with no evidence of heat applied to the rh.However, the luer activated valve (lav) was found to be cracked.The conditions observed on the embolic coil and rh reasonably suggest that the issue was noticed before the embolic coil was pushed outside the introducer and before any detachment attempt, but the lav could have been inadvertently hit by another object when it was taken out of the package, causing the crack and the subsequent leakage encountered during the procedure.The damage observed on the lav can also be related to the incompatibility reported by the user.Considering the factors described above, the customer complaint was confirmed.A manufacturing record evaluation was performed, and no non-conformances were identified.Assignment of root cause for the events 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 failures and damages on the returned system.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: OG CMPLX XTRASOFT COIL 3.5X7.5
• 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. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13010464
• Report Number: 3008114965-2021-00674
• Device Sequence Number: 1766354
• Product Code: KRD
• UDI-Device Identifier: 10886704030706
• UDI-Public: 10886704030706
• Combination Product (Y/N): N
• PMA/510(K) Number: K093973
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2022

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: 07/31/2022
• Device Model Number: 640CX3575
• Device Catalogue Number: 640CX3575
• Device Lot Number: 30436668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 01/24/2022; 02/16/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/27/2022; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2020
• 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
• Patient Sex: Unknown