MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUFILL DCS SYRINGE II; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	635-002
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2020
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.Initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a stent-assisted aneurysm embolization, the trufill dcs syringe ii (635002, 96331354) did not pressurize as intended.There was a crack on the tip of the wire, the syringe is under air leakage.The unspecified coil system couldn't be detached.The physician switched to another syringe and the procedure was completed.There was not injury reported.The coil delivery system was prepped without any difficulty.The syringe was filled with saline from a dedicated source of saline.The syringe had not been used to successfully detach any coils prior to this one.Prior to attempting to detach, it was verified under fluoro that there was no stress against the headway17 microcatheter (mc) or delivery tube.The same syringe had not previously exceeded the green zone/position #3.After the coil did not detach at the syringe green zone, it was not attempted to deploy the coil at the syringe red alternative detachment zone.Subsequent coils were detached with another syringe.The device was received for product analysis.It was noted that the gauge needle was in the zero position when received.It was also noted that the lot identification that is externally stamped on the gauge housing by atrion¿s gauge supplier had worn off and was no longer visible.There were no anomalies noted in the visual inspection.The device was connected to a pressure indicator, and plunger pulled to fill the device with distilled water for aspiration.The latch was engaged, and the plunger was rotated clockwise to pressurize the device.As the device was pressurized, the gauge did not respond.After being pressurized for approximately 5 minutes, the gauge needle still did not respond.The filter was then inspected under magnification.The filter exhibited crystallized corrosion.The crystallized substance which corrodes the gauge filter, blocks the flow of water, and prevents the gauge indicator from functioning when the inflator is pressurized.This condition is found when certain liquid compounds are left inside the filter and evaporate over time leaving mineral deposits that lead to clogging or blocking of the filter, and ultimately lead to a loss of functionality of the gauge; which is indicative of multiple uses of the device.A review of the device history record for the indicated lot revealed everything met the acceptance criteria.The reported customer complaints of ¿cnv syringe - difficulty to detach-does not detach coil¿, cnv syringe ¿ leakage¿ and ¿cnv syringe ¿ cracked¿ were not confirmed.The returned device exhibited crystallized corrosion on the gauge filter, and the lot identification of the gauge, which is stamped on the gauge housing by atrion¿s gauge supplier, was no longer visible; all of which is indicative of multiple uses of the device.As a reminder, atrion¿s medical products are all validated for single-use application.Due to atrion¿s rigorous final assembly step of 100% pressure, leakage, vacuum and gauge accuracy testing, and the fact that no liquid is ever introduced in atrion¿s manufacturing and testing processes, atrion does not believe that the device left our facility in an occluded condition.The trufill dcs syringe ii is intended for single use only; do not resterilize.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.
Event or Problem Description
As reported by the field, during a stent-assisted aneurysm embolization, the trufill dcs syringe ii (635002, 96331354) did not pressurize as intended.There was a crack on the tip of the wire, the syringe is under air leakage.The unspecified coil system couldn't be detached.The physician switched to another syringe and the procedure was completed.There was no injury reported.The coil delivery system was prepped without any difficulty.The syringe was filled with saline from a dedicated source of saline.The syringe had not been used to successfully detach any coils prior to this one.Prior to attempting to detach, it was verified under fluoro that there was no stress against the headway17 microcatheter (mc) or delivery tube.The same syringe had not previously exceeded the green zone/position #3.After the coil did not detach at the syringe green zone, it was not attempted to deploy the coil at the syringe red alternative detachment zone.Subsequent coils were detached with another syringe.

• Brand Name: TRUFILL DCS SYRINGE II
• 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: 11279510
• Report Number: 3008114965-2021-00071
• Device Sequence Number: 3691499
• Product Code: HCG
• UDI-Device Identifier: 10886704029410
• UDI-Public: 10886704029410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063254
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2021

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: 01/31/2022
• Device Model Number: 635-002
• Device Catalogue Number: 635002
• Device Lot Number: 96331354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1