MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 2.5X3.5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX2535
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
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.Visual analysis was performed on the photos provided.Only one section of the og cmplx xtrasoft coil 2.5x3.5 could be noted in the picture, in this, we can appreciate that the hypo-tube is broken into two pieces.The rest of the device remains inside of the hoop and cannot be evaluated.No other damages could be noted.A manufacturing record evaluation was performed for the finished device 30641872 number, and no non-conformances related to the malfunction were identified.The reported condition "detachable coil delivery system (dcs)- leakage" could not be evaluated based on the pictures.The reported condition "delivery tube- separated-during use" was confirmed since the hypo-tube could be noted broken into two pieces.However, the exact time when this condition occurs cannot be determined.The mre suggests that the failure reported by the customer could not be related to the manufacturing process.No corrective action will be taken at this time.Further investigation will be performed once the device returns for analysis.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, during a coil embolization, when a physician tried to inflate the syringe to detach an orbit galaxy xtrasoft coil (640cx2535, 30641872), the saline was leaking and detachment failed.Therefore, the physician tried to increase the pressure of the syringe to give another try to detach the coil, and the wire near the hub became broken.The physician reported that it was a defect of product, or an assistant gave too much pressure on it, but because of the leaking problem, more pressure was inevitable.This coil was taken out of the patient's body because of detachment failure.A same like product was used and the procedure was completed successfully.
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, during a coil embolization, when a physician tried to inflate the syringe to detach an orbit galaxy xtrasoft coil (640cx2535, 30641872), the saline was leaking, and detachment failed.Therefore, the physician tried to increase the pressure of the syringe to give another try to detach the coil, and the wire near the hub became broken.The physician reported that it was a defect of product, or an assistant gave too much pressure on it, but because of the leaking problem, more pressure was inevitable.This coil was taken out of the patient's body because of detachment failure.A same like product was used and the procedure was completed successfully.A non-sterile og cmplx xtra soft coil 2.5x3.5 was received for analysis, the hypotube was observed to be separated into two pieces near the strain relief component and a kink was observed at 8 inches from the proximal end.Both hypo-tube fragments were noted to have the tip curved.Saline residues were observed on the proximal portion of the hypotube, and further inspection revealed that there was saline solution adhered on the distal surface of the luer valve thread.No further test could be performed due to the condition noted on the hypotube.A manufacturing record evaluation (mre) was performed for the finished device 30641872 number, and no non-conformances related to the malfunction were identified.The photo was provided in which only one section of the device could be noted in the picture, in this, we can appreciate that the hypo-tube is broken into two pieces.The rest of the device remains inside the hoop and cannot be evaluated.No other damages could be noted.The device was returned to cerenovus for further evaluation.Upon arrival, the hypo-tube was observed to be separated into two pieces near the strain relief component and a kink was observed at 8 inches from the proximal end.The kink might have appeared sometime during the post-operative handling or decontamination process, and it is not related to the failure modes reported.The hypo-tube was inspected under microscopic magnification, and both hypo-tube fragments were noted to have the tip curved; when the curved ends were matched, the hypo-tube formed an angle, which suggests that the hypo-tube was kinked and led to the fracture observed.The customer complaint regarding the separation of the hypo-tube was confirmed.Under microscopic inspection, saline residues were observed on the proximal portion of the hypo-tube, and further inspection revealed that there was saline solution adhered on the distal surface of the luer valve thread.This indicates that the leakage was coming towards the distal end, however, the source of the leakage could not be identified.Although the leakage experienced during the procedure could not be replicated due to the hypo-tube separation, the saline residues found on the proximal hypo-tube and luer valve are indication of the leakage encountered during the procedure.Therefore, the customer complaint regarding leakage was confirmed.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 modes.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure could be caused by multiple factors.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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Updated sections on this medwatch: b4, 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.

• Brand Name: OG CMPLX XTRASOFT COIL 2.5X3.5
• 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: 13471103
• Report Number: 3008114965-2022-00080
• Device Sequence Number: 14485315
• Product Code: KRD
• UDI-Device Identifier: 10886704030676
• UDI-Public: 10886704030676
• 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): 03/31/2022

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: 07/31/2023
• Device Model Number: 640CX2535
• Device Catalogue Number: 640CX2535
• Device Lot Number: 30641872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 02/28/2022; 03/25/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/10/2022; 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• 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