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

Catalog Number	640CX2535
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, there was resistance while pushing the orbit galaxy xtrasoft coil (640cx2535, 30758099) in the unspecified microcatheter (mc).When the coil was removed, it was stretched.There was no patient injury reported.There was a five-minute procedural delay due to the event.The procedure was successfully completed.Additional event information was received on 13-jan-2024 indicating that the resistance was first felt inside the mid shaft of the prowler select lpes lot (606s155x, 31041133, lot unknown) microcatheter.Before the resistance, two coils had been used and after the encountered resistance, one coil was used.The event did result in a loss of cerebral target position.The mc was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.There was nothing noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.No excessive force was applied to the device.The physician did not feel that the procedural delay was clinically significant.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 as indicated as ¿other¿ in this section as the reason for non-evaluation.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00100.
Additional Manufacturer Narrative
Product complaint #(b)(4).Complaint conclusion: as reported by the field, during a coil embolization, there was resistance while pushing the 2.5mm x 3.5cm orbit galaxy complex fill xtrasoft (640cx2535, 30758099) in the unspecified microcatheter (mc).When the coil was removed, it was stretched.There was no patient injury reported.There was a five-minute procedural delay due to the event.The procedure was successfully completed.Additional event information was received on 13-jan-2024 indicating that the resistance was first felt inside the mid shaft of the prowler select lpes lot (606s155x, 31041133, lot unknown) microcatheter.Before the resistance, two coils had been used and after the encountered resistance, one coil was used.The event did result in a loss of cerebral target position.The mc was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.There was nothing noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.No excessive force was applied to the device.The physician did not feel that the procedural delay was clinically significant.A non-sterile 2.5mm x 3.5cm orbit galaxy complex fill xtrasoft was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no apparent damage was observed.The coil component was inspected under microscopic magnification, it was found that the embolic coil is in good normal conditions (i.E., no elongations, kinks, or non-concentric loops were noted).A lab sample prowler select plus was flushed until the water was coming out from the distal end.Then, the orbit galaxy was introduced into the microcatheter, and it advanced; the orbit galaxy could be advanced until it came out from the distal tip of the microcatheter without noticeable resistance.The functional test was performed successfully with one sample prowler select plus, the device was able to pass through the entire length of the microcatheter without significant resistance.Additionally, no other damages were found on the orbit galaxy that could have contributed to the issue reported during the procedure.The customer complaint cannot be confirmed with the evidence available.It is possible that other clinical and procedural factors that cannot be replicated during the analysis may have contributed to the reported failure.A manufacturing record evaluation was performed for the finished device 30758099 number, and no non-conformances related to the malfunction were identified.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If unusual friction is noted within the infusion catheter, remove the detachable coil system.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.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.

• 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): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18553172
• Report Number: 3008114965-2024-00099
• Device Sequence Number: 6411829
• Product Code: KRD
• UDI-Device Identifier: 10886704030676
• UDI-Public: 10886704030676
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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: 01/31/2024
• Device Catalogue Number: 640CX2535
• Device Lot Number: 30758099
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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: PROWLER SELECT LPES
• Patient Sex: Male