MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 2MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number DLX100206

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, it was reported that all three (3) 2mm x 6cm deltaxsft 10 coils (dlx100206) from the same lot (30537004) could not be pushed out of the introducer sheath.The coils were appropriately flushed.After an increase in pressure to advance the coil out of the introducer sheath, the delivery wire of one of the coils became protruded from the introducer sheath.Additional information received indicated that the tip of the introducer was firmly installed into the hub of the concomitant excelsior® xt-17¿ microcatheter (stryker) and locked with the rotating hemostasis (rhv) during the device advancement.The concomitant was maintained in the target vessel.The same microcatheter was used to successfully treat the target vessel with other cerenovus coils.It was indicated that pushing force had been increased when resistance was felt, but the force was not excessive.There was no report of any patient adverse event or patient complication.The complaint devices were returned for evaluation and analysis.During the microscopic inspection of the 2mm x 6cm deltaxsft 10 coil, the embolic coil was observed stuck inside the introducer and in stretched condition.Based on the product analysis on 28 dec 2021, this event has been deemed mdr reportable as a ¿malfunction.¿.

Manufacturer Narrative

Manufacturer¿s ref.No:(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.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, it was reported that all three (3) 2mm x 6cm deltaxsft 10 coils (dlx100206) from the same lot (30537004) could not be pushed out of the introducer sheath.The coils were appropriately flushed.After an increase in pressure to advance the coil out of the introducer sheath, the delivery wire of one of the coils became protruded from the introducer sheath.Additional information received indicated that the tip of the introducer was firmly installed into the hub of the concomitant excelsior® xt-17¿ microcatheter (stryker) and locked with the rotating hemostasis (rhv) during the device advancement.The concomitant was maintained in the target vessel.The same microcatheter was used to successfully treat the target vessel with other cerenovus coils.It was indicated that pushing force had been increased when resistance was felt, but the force was not excessive.There was no report of any patient adverse event or patient complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 2mm x 6cm deltaxsft 10 coil was received.Visual inspection was performed.The complaint device was observed to be in good, normal condition without any damages nor anomalies.Microscopic inspection was performed.Under magnification, the embolic coil component is observed stuck inside the introducer in stretched condition.Functional test could not be performed due to the condition of the embolic coil being stuck inside the introducer in stretched condition.A review of manufacturing documentation associated with this lot (30537004) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's 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.The complaint documented that during the procedure, all three (3) coils could not be pushed out of the introducer sheath.Additional information indicated that the pushing force had been increased when resistance was felt, but the force was not excessive.During the microscopic inspection, the embolic coil was observed stuck inside the introducer, this observation confirmed the reported issue that the coil was impeded in the introducer sheath.The stretched condition of the coil may have been the result of the increased in pushing force when the coil became impeded ¿ it was pushed and likely pulled back causing the coil to stretch.The exact cause of the stretched coil condition cannot be conclusively determined.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.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.Refer to coil retrieval.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.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.Stretching can occur during procedure handling where force may have been inadvertently applied.The stretched condition of the embolic coil was not originally reported in the complaint.The exact cause of the stretched condition of the coil cannot be conclusively determined; however, it is possible that when the coil was impeded the introducer sheath and the pushing force was increased in attempt to advance it out of the introducer, though the force was indicated as not excessive, was enough that it may have been a factor in the observed stretched condition.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that 2mm x 6cm deltaxsft 10 coil left the manufacturing facility with the embolic coil in stretched condition.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 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00782 and 3008114965-2021-00784.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.

• Brand Name: DELTAXSFT10 2MM X 6CM
• Type of Device: 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. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13101627
• MDR Text Key: 289964155
• Report Number: 3008114965-2021-00783
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077336
• UDI-Public: 10886704077336
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: DLX100206
• Device Catalogue Number: DLX100206
• Device Lot Number: 30537004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELTAXSFT10 2MM X 6CM; DELTAXSFT10 2MM X 6CM; EXCELSIOR® XT-17¿ MICROCATHETER (STRYKER)