MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 5X15; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0515
Medical Device Problem Codes	Positioning Failure (1158); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.(b)(6).The initial reporter email address is not reported / available.[conclusion]: the healthcare professional reported that during a stent-assisted aneurysm coil embolization procedure, it was reported that the 5mm x 15cm orbit galaxy complex fill coil (640cf0515 / 30401399) could not be withdrawn because the zipper became stuck.The physician switched to a new coil to complete the procedure.There was no report of any patient adverse event or complication.Additional information was provided on 10 may 2021.The information indicated that the concomitant microcatheter (unspecified brand) dropped of the aneurysm and had to be adjusted.Adequate and continuous flush was maintained through the microcatheter.There was no damage to the introducer sheath.There was no resistance at any time during the advancement of the coil through the microcatheter.The coil was not positioned at a sharp angle to the microcatheter and there was a one-to-one relationship between the coil and the delivery system verified with fluoroscopy prior to repositioning.The coil was removed from the patient and replaced.No additional intervention was required and the reported issue did not result in any blood flow restriction / reduction.The complaint coil was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 5mm x 15cm orbit galaxy complex fill coil was received contained in a pouch.Visual inspection was performed.It was observed that the coil introducer is separated from the rest of the device with part of the embolic coil stretched and protruding from it.No other damages nor anomalies were observed during the visual inspection.Microscopic inspection was performed.The embolic coil was confirmed to be in stretched condition as observed during the visual inspection.The embolic coil is protruding from the introducer.The introducer was noted to be in good, normal condition.The support coil was also inspected and was observed without any appearance of damage.This suggests that the embolic coil was not mechanically detached.Functional testing could not be performed with the introducer being separated from the rest of the device.The embolic coil was also protruding from the introducer and in stretched condition.A review of manufacturing documentation associated with this lot (30401399) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint reported that the during the procedure, the coil could not be withdrawn because the zipper became stuck.The additional information received reported that the concomitant microcatheter dropped ff the aneurysm and had to be adjusted.The returned complaint coil was observed to be stretched and protruding from the introducer which was observed to be in good condition.Though functional testing was precluded due to the condition of the returned complaint device, the reported issues were confirmed based on the visual and microscopic inspection where the embolic coil was observed stretched and protruding from the introducer, which is the likely contributing factor for the reported issue that the zipper became stuck.The coil became stretched, which is the likely cause of the reported issue that the coil could not be withdrawn.It should be noted that product failure is multifactorial.The instructions for use (ifu) does contain the following direction: 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.Coil stretching 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.The condition of the coil appears to be due to inadvertent force applied to the device during procedure handling, though this cannot be conclusively determined.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 5mm x 15cm orbit galaxy complex fill coil left the manufacturing facility with the device kinked and entangled, with the coil introducer in kinked condition and the embolic coil stretched and protruding from the introducer as observed during the visual and microscopic inspections.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 a stent-assisted aneurysm coil embolization procedure, it was reported that the 5mm x 15cm orbit galaxy complex fill coil (640cf0515 / 30401399) could not be withdrawn because the zipper became stuck.The physician switched to a new coil to complete the procedure.There was no report of any patient adverse event or complication.Additional information was provided on 10 may 2021.The information indicated that the concomitant microcatheter (unspecified brand) dropped of the aneurysm and had to be adjusted.Adequate and continuous flush was maintained through the microcatheter.There was no damage to the introducer sheath.There was no resistance at any time during the advancement of the coil through the microcatheter.The coil was not positioned at a sharp angle to the microcatheter and there was a one-to-one relationship between the coil and the delivery system verified with fluoroscopy prior to repositioning.The coil was removed from the patient and replaced.No additional intervention was required and the reported issue did not result in any blood flow restriction / reduction.The complaint device was returned for evaluation.During the visual and microscopic inspections of the returned device, the embolic coil was observed in stretched condition.Based on the product analysis on 04 june 2021, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: OG TDL CMPLX FILL COIL 5X15
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11943075
• Report Number: 3008114965-2021-00239
• Device Sequence Number: 19890413
• Product Code: KRD
• UDI-Device Identifier: 10886704030300
• UDI-Public: 10886704030300
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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: 05/31/2022
• Device Model Number: 640CF0515
• Device Catalogue Number: 640CF0515
• Device Lot Number: 30401399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1