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

Catalog Number	640CX3575
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the name, phone and email address of the initial reporter are not available / reported.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil was received contained in the decontamination pouch.Visual inspection was performed.A kink was observed on the introducer.Multiple kinks were observed on the hypotube.The embolic coil was returned outside of the introducer.Microscopic inspection was performed.Under magnification, the embolic coil was observed severely kinked but still attached to the gripper.The issue regarding a coil sheath not being able to be re-zipped was confirmed since the kink damage found on the introducer prevented the zipper from advancing past the kink present on the introducer resulting in the inability to re-sheath the device.According to the risk documentation, product damage of the retrieved device is a potential issue that can occur during embolic coil retrieval due to the introducer handling and anchoring techniques (rezipping, zipper movement, introducer locking, etc.), which can result in the introducer damage.There is no indication that the issue reported is a result of a defect inherently related to the device.The coil kinking was not originally documented in the complaint, and its exact time of occurrence cannot be determined since no further information was gathered from the customer.It is possible that the coil became kinked during the unit withdrawal due to rotative hemostasis valve (rhv) overtightening or during the post-operative handling of the device.This condition and the multiple kinked conditions noted on the hypo-tube are not considered related to the issue as reported.A review of manufacturing documentation associated with this lot (30880056) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at final assembly to prevent damage from leaving the manufacturing site.Since there was no evidence to suggest the event was related to a manufacturing or design issue.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 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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.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 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, the complaint coil, a 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil (640cx3575 / 30880056) was the first coil used.It was reported that the physician ¿decided to pull it out for re-deployment after trying another size of coil first.Because the size of the coil was not appropriate with the aneurysm.During re-sheathing of the coil, the introducer failed to be re-zipped.The physician used a same like product.The procedure was successfully completed.¿ there was no report of any negative patient impact.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The product was returned for evaluation and analysis.Based on the result of the product analysis completed on 13-jun-2024, the reported issue meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".

• 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): 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 ; 303552-6892
• MDR Report Key: 19536723
• Report Number: 3008114965-2024-00614
• Device Sequence Number: 6425382
• Product Code: KRD
• UDI-Device Identifier: 10886704030706
• UDI-Public: 10886704030706
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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: 06/30/2024
• Device Catalogue Number: 640CX3575
• Device Lot Number: 30880056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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
• Patient Sex: Unknown