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

Model Number	635-002
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.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.A review of manufacturing documentation associated with this lot (96331358) 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.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 the procedure, the physician felt water leaking during the attempt to detach the coil using the trufill dcs syringe ii (635002 / 96331358).The physician replaced it with another trufill dcs syringe ii, and the procedure was successfully completed.A comment made was that the trufill was difficult to use because ¿water keeps leaking out.¿ there was no report of any patient adverse event or complications.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the procedure, the physician felt water leaking during the attempt to detach the coil using the trufill dcs syringe ii (635002 / 96331358).The physician replaced it with another trufill dcs syringe ii, and the procedure was successfully completed.A comment made was that the trufill was difficult to use because ¿water keeps leaking out.¿ there was no report of any patient adverse event or complications.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is available at a later date and the product is returned, the file will be updated accordingly.The device was returned for evaluation and analysis.The investigation was performed by the original equipment manufacturer (oem) atrion.The investigation is documented below.Visual inspection: the device was received in a pouch labeled as complaint (b)(4) it was noted that the gauge needle was in the zero position for the device.It was also noted that lot identification information that is stamped on the outside of the gauge by atrion¿s gauge supplier is no longer visible on the gauge housing of the device; the device exhibited hole or blown portions / damage in the hose.There was crazing noted on various areas of the housing of the device.Functional evaluation: functional testing was performed.The device was connected to a pressure indicator, and the plunger pulled to fill the device with distilled water for aspiration.Due to water leaking from the blown portion of the hose, multiple attempts had to be made in order to fill the device with enough water for functional testing.After filling the device, the device was latched, and plunger rotated clockwise to pressurize the device.The device could not build pressure as water would leak from the damaged hose as pressure increased.Therefore, functional testing was discontinued, and further evaluation was performed on the gauge.The gauge was un-torqued and removed from the complaint device.The filter was then inspected under magnification.The filter exhibited crystallized corrosion.Investigation conclusion: current manufacturing controls include 100% automation testing for pressure leakage, pressure decay, vacuum decay, and gauge accuracy during manufacture using ultra high purity nitrogen gas before leaving the manufacturing facility.Devices that pass this test are marked by automation for identification.Devices that failed are not marked.The returned device was marked, indicating that it met manufacturing specifications when it left the facility.A review of the device history record for the indicated lot revealed everything met the acceptance criteria.25 devices are functionally tested with distilled water for gauge accuracy and pressure cycled.All 25 devices tested in lot 96331358 passed the in-process testing.The devices that are functionally tested with water are all disposed of upon completion of testing.In addition, all devices are 100% automation tested with ultra-pure nitrogen for functional compliance during manufacture, which checks each device for proper gauge orientation, responsiveness, pressure accuracy (from vacuum to maximum gauge capacity), and device seal integrity.The returned device exhibited excessive crazing indicative of extreme abuse, either from heat or chemical treatment.Additionally, the gauge face was distorted / warped in the lower right-hand area indicative of exposure to excessive heat.The gauge filter of the returned device exhibited crystallized corrosion.The crystallized substance which corroded the gauge filter, blocks the flow of water, and prevents the gauge indicator from functioning when the inflator was 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.Further, the lot identification that is externally stamped on the gauge by atrion¿s gauge supplier, has been worn off or removed from the gauge of the device.The crazing, warped gauge face, corroded gauge filter, and worn or removed gauge lot identification, all are indicative of multiple uses of the device.Atrion¿s medical products are all validated for single-use application.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.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the returned complaint device on 05 february 2021.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: d.9, g.3, g.6.H.2, h.3, h.6, and h.10.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: 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: 11227120
• Report Number: 3008114965-2021-00009
• Device Sequence Number: 3571771
• Product Code: HCG
• UDI-Device Identifier: 10886704029410
• UDI-Public: 10886704029410
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2021

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: 96331358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/05/2021; 02/25/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/05/2021; 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1