MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 2.5X5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX2505
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
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.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.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, the detachment hub of an orbit galaxy xtrasoft (640cx2505, 30494095) was broken when it was first open.The physician decided to use a same-like product and the case was successfully done.Additional information received indicated that the user explained that the luer seemed broken or cracked when it was first open.She felt more it was cracked while she connected the coil hub and luer (locking the luer).The user is not sure whether it¿s because she put more pressure than recommended to tighten them or there was a damage already.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h10.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 (640cx2505, 30494095) was broken when it was first open.The physician decided to use a same-like product and the case was successfully done.Additional information received indicated that the user explained that the luer seemed broken or cracked when it was first open.She felt more it was cracked while she connected the coil hub and luer (locking the luer).The user is not sure whether it¿s because she put more pressure than recommended to tighten them or there was a damage already.A non-sterile og cmplx xtra soft coil 2.5x5 was received inside of a pouch.No 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.No further testing could be performed due to the condition noted on the lav.A manufacturing record evaluation was performed for the finished device 30494095 number, and no non-conformances related to the reported complaint condition were identified the product was returned to cerenovus for evaluation.Visual inspection of the returned og cmplx xtra soft coil 2.5x5 revealed no apparent damage to the device.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.Customer complaint was confirmed due to the findings observed.However, the event description and device analysis do not provide clear insight into the root cause and/or exact contributing factors that may have resulted in the observed failure mode.A manufacturing record evaluation was performed, and no non-conformances were identified.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: OG CMPLX XTRASOFT COIL 2.5X5
• 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: 13014320
• Report Number: 3008114965-2021-00680
• Device Sequence Number: 1816627
• Product Code: KRD
• UDI-Device Identifier: 10886704030652
• UDI-Public: 10886704030652
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2022

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: 11/30/2022
• Device Model Number: 640CX2505
• Device Catalogue Number: 640CX2505
• Device Lot Number: 30494095
• 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; 02/17/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/28/2022; 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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