MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 4X12; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0412
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
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.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 3008114965-2023-00594.
Event or Problem Description
As reported by the field, during a coil embolization, there was resistance while pushing an orbit galaxy coil (640cf0412, 30842964) in the unspecified microcatheter (mc), when the coil was removed it was stretched.The surgery was delayed by 10 minutes due to the reported event.Another coil was used to complete the successful procedure.No patient injury was reported.Additional information was received indicating that the mc used, was a prowler select lpes 45 deg tip (606s155fx, 30763314).The resistance was encountered at the distal shaft of the mc.Other devices were successfully used with the microcatheter prior to the encountered resistance.The event did result in a loss of cerebral target position.The microcatheter was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.Nothing was 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.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h10.Complaint conclusion: as reported by the field, during a coil embolization, there was resistance while pushing an orbit galaxy coil (640cf0412, 30842964) in the unspecified microcatheter (mc), when the coil was removed it was stretched.The surgery was delayed by 10 minutes due to the reported event.Another coil was used to complete the successful procedure.No patient injury was reported.Additional information was received indicating that the mc used, was a prowler select lpes 45 deg tip (606s155fx, 30763314).The resistance was encountered at the distal shaft of the mc.Other devices were successfully used with the microcatheter prior to the encountered resistance.The event did result in a loss of cerebral target position.The microcatheter was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.Nothing was 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.A non-sterile 4mm x 12cm orbit galaxy complex fill coil was received contained in the decontamination pouch.Upon receipt of the device, visual inspection was performed, the coil component was observed severely stretched; two fragments of the coil were observed.No other damages were noted.Microscopic examination was performed.Under magnification, it was observed that a portion of the coil was completely straightened and snapped, the blue stretch resistance fiber was exposed; the proximal fragment of the coil remained attached to the headpiece, which was observed undamaged.The issue documented in the complaint that there was resistance while pushing the coil through the microcatheter could not be evaluated through functional testing since the coil became stretched during the procedure.There are no additional damages noted on the delivery system to suggest that the device was forcibly advanced through the microcatheter in attempt to overcome the resistance encountered.The issue documented that the coil became stretched when it was removed was confirmed based on the appearance of the returned device.According to the risk documentation, product damage of the retrieved device is a hazard that can occur due to the introducer not being seated all the way into the microcatheter hub or insufficient opening of the rotative hemostasis valve (rhv), which can result in coil stretching.Additional factors such as delivery system/introducer handling and anchoring techniques (e.G.Rezipping, zipper movement, introducer locking) may also contribute to the coil stretching.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is proposed at this time.It should be noted that product failure is multifactorial.The instructions for use contain the following precautions and warnings: ¿ do not withdraw or torque the delivery tube against resistance without first determining the cause of the resistance under fluoroscopy.These manipulations of the delivery tube against resistance can cause damage and/or premature detachment of the coil.¿ during coil retraction, verify under fluoroscopy that a one-to-one relationship exists between the delivery tube and the coil.If not, the coil has been stretched, which could lead to premature detachment or coil fracture.If the one-to-one relationship does not exist, remove the infusion catheter and the detachable coil as an assembly and replace.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 TDL CMPLX FILL COIL 4X12
• 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: 17557203
• Report Number: 3008114965-2023-00593
• Device Sequence Number: 3640177
• Product Code: KRD
• UDI-Device Identifier: 10886704030270
• UDI-Public: 10886704030270
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 05/31/2024
• Device Catalogue Number: 640CF0412
• Device Lot Number: 30842964
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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 45 DEG TIP
• Patient Age: 14 YR
• Patient Sex: Female