MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 2.5X2.5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX2525
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.The initial reporter phone and email address were not available / reported.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure, while advancing the 2.5mm x 2.5cm orbit galaxy complex xtrasoft coil (640cx2525 / 30566748) through the microcatheter, there was resistance and the coil became stuck / impeded in the microcatheter.The coil was removed and another coil, a 2mm x 1.5cm orbit galaxy complex xtrasoft (640cx0201 / 30628887) was used but the coil got stretched.The reported event delayed the procedure for half an hour, it was not reported whether this delay was clinically significant.It was reported that the procedure was successfully completed; there was no report of any patient adverse event or injury.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 2.5mm x 2.5cm orbit galaxy complex xtrasoft coil was received.Visual inspection was performed.The complaint device was observed to have multiple bends along its entire length.Due to the condition of the returned device, functional testing could not be performed.Microscopic inspection was performed.Under magnification, the embolic coil was observed kinked but still attached to the rest of the device.No other damages nor anomalies were observed on the device.The multiple bends observed on the hypotube could be related to the post-operative handling of the device since these damages are not documented on the complaint; it is possible that these damages occurred when the device was folded and packed to undergo the decontamination process.However, based on the description of the customer complaint, the most likely cause of such damages is that in an attempt to overcome the immobility of the coil inside the microcatheter, undue force might have inadvertently been applied resulting in the hypotube bending.Coil kinking is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Kinking can occur during procedure handling where force may have been inadvertently applied.The complaint documented that the coil was not going smooth and it got stuck inside the micro catheter.It is possible that force may have inadvertently been applied during the coil advancement through the microcatheter which resulted in the coil kinking.Although the conditions noted on the device precluded proper testing, based on the findings during the inspection, the customer complaint was confirmed, the multiple damages found in the device may be the result of the difficulties experienced while maneuvering the device as a result of the impeded condition reported by the customer.A review of the manufacturing documentation associated with this lot (30566748) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use do contain the following precaution: 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 for statistical signals and corrective / preventive action may be triggered at a later time.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.This is one of the products involved with the reported complaint.The associated manufacturer report number : 3008114965-2022-00318.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, while advancing the 2.5mm x 2.5cm orbit galaxy complex xtrasoft coil (640cx2525 / 30566748) through the microcatheter, there was resistance and the coil became stuck / impeded in the microcatheter.The coil was removed and another coil, a 2mm x 1.5cm orbit galaxy complex xtrasoft (640cx0201 / 30628887) was used but the coil got stretched.The reported event delayed the procedure for half an hour, it was not reported whether this delay was clinically significant.It was reported that the procedure was successfully completed; there was no report of any patient adverse event or injury.The complaint device was returned for analysis.During the microscopic inspection, the coil was observed to be in a kinked condition.Based on the result of the product analysis completed on 20-jun-2022, the event has been deemed reportable as a ¿malfunction.¿.

• Brand Name: OG CMPLX XTRASOFT COIL 2.5X2.5
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14749747
• Report Number: 3008114965-2022-00448
• Device Sequence Number: 12274034
• Product Code: KRD
• UDI-Device Identifier: 10886704030669
• UDI-Public: 10886704030669
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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: 03/31/2023
• Device Model Number: 640CX2525
• Device Catalogue Number: 640CX2525
• Device Lot Number: 30566748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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