MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 1.5MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number DLX100152

Device Problem Failure to Advance (2524)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during an external carotid artery embolization due to a gunshot wound, the physician encountered issues with four (4) coils.The first two coils, a 11mm x 37cm micrusframe 18 (mfr181137 / 30537032) and a 12mm x 40cm micrusframe 18 (mfr181240 / 30670821) would not detach after more than five (5) cycles were made to attempt to detach them.The third coil, a 1.5mm x 2cm deltaxsft 10 (dlx100152 / 30633423) and the fourth coil, a 1.5mm x 3cm deltaxsft 10 (dlx100153 / 30652463) would not advance due to broken string on the lock mechanism.The physician moved to a different product to finish the procedure.There was no report of injury to the patient.The procedure was successfully completed.On 13-jul-2023, additional information was received.The information indicated that the patient is a male under 18 years of age.The concomitant microcatheter used for all the coils was a 0.017 id headway® duo 156 microcatheter (microvention).The additional information related to the 11mm x 37cm micrusframe 18 (mfr181137 / 30537032) indicated the following: the coil was not stretched when it was removed, it was still attached to the delivery system.A pre-deployment electrical check was performed.No fault light was seen.Upon pressing the power button, all lights illuminated.The green system ready light did illuminate and the audible signal beep was heard.All connection fit properly without application of excessive force.The additional information related to the 12mm x 40cm micrusframe 18 (mfr181240 / 30670821) indicated the following: the coil was not stretched when it was removed, it was still attached to the delivery system.A pre-deployment electrical check was performed.Fault light was seen during the use of this coil.Upon pressing the power button, all lights illuminated.The green system ready light did illuminate and the audible signal beep was heard.All connection fit properly without application of excessive force.The related to the remaining two coils: 1.5mm x 2cm deltaxsft 10 (dlx100152 / 30633423) 1.5mm x 3cm deltaxsft 10 (dlx100153 / 30652463), continuous flush was maintained through the microcatheter during the procedure and during the use of both of these coils.Per the additional information, three (3) flush systems used: one (1) to the sheath, 1 to the guide and 1 to the microcatheter.The additional information indicated that reported issues did result in a non-clinically significant but frustrating delay in the procedure.The 1.5mm x 2cm deltaxsft 10 (dlx100152 / 30633423) was returned for evaluation and analysis.The product investigation completed on 30-aug-2023.Based on the completed product investigation, this event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Section d.2b: procode is krd/hcg.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 1.5mm x 2cm deltaxsft 10 was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the coil was tangled with the rest of the delivery system.The embolic coil component was inspected under the microscope.Under magnification, it was observed to be in severely stretched condition and the blue fiber was exposed due to the stretching coil.The embolic coil remained attached to the resistance heating (rh) coil.The rh coil sheathing was observed not softened; an indication that the detachment process had not been initiated.The issue documented regarding the resistance between the complaint coil and the lock mechanism could not be evaluated through functional testing due to the condition of the returned coil; however, the issue reported can be confirmed based on the appearance of the coil component.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 issues from occurring.According to risk documentation, friction/difficulty to advance is a potential effect of inability to position microcoil and improper position during microcoil placement, which can result in coil stretching.There is no indication that the issue reported is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30633423) 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 for coil condition to prevent coil damage from leaving the facility.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does contain the following recommendations: ¿ if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.¿ if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw, and examine the delivery catheter system.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 4 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00482, 3008114965-2023-00483, and 3008114965-2023-00631.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.

• Brand Name: DELTAXSFT10 1.5MM X 2CM
• 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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17656950
• MDR Text Key: 322504360
• Report Number: 3008114965-2023-00630
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077251
• UDI-Public: 10886704077251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DLX100152
• Device Lot Number: 30633423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2021
• 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: HEADWAY® DUO 156 MICROCATHETER (MICROVENTION)
• Patient Sex: Male