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 Consequences Or Impact To Patient (2199)
Date of Event	08/09/2020
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.A review of manufacturing documentation associated with this lot (96331357) 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 / 96331357).The physician replaced it with another trufill dcs syringe ii, and the procedure was successfully completed.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 / 96331357).The physician replaced it with another trufill dcs syringe ii, and the procedure was successfully completed.There was no report of any patient adverse event or complications.On 13 january 2021, the product analysis lab received two trufill dcs syringe ii.The investigation for the first of the two returned devices is documented below.Investigation summary: the investigation was performed by the original equipment manufacturer (oem).Two complaint devices were returned for evaluation.Visual inspection was performed upon the receipt of the complaint devices.Device 1: it was noted that the gauge needle of the device was in the zero position.The device exhibited yellowing on the attached hose.The lot identification that is externally stamped on the gauge housing by atrion¿s gauge supplier, is missing and is no longer visible on the device.There were no anomalies noted in the visual inspection.After the completion of the visual inspection.Functional testing was performed.The device was connected to the 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, no leaking was observed, but the gauge did not respond.After being pressurized for approximately 5 minutes, there was still no leakage and the gauge needle still did not respond.Functional testing was discontinued, and a thorough evaluation was performed on the gauge.The gauge was un-torqued and removed from the complaint device.The filter of the gauge was then inspected under magnification.The filter exhibited 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.Since this complaint was not in regard to any issue with the gauge, further evaluation and testing was ceased.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 (dhr) for the indicated lot: (96331357) 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: 96331357 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 complaint device exhibits the cts mark indicating 100% functionality at time of manufacturing.The returned device did not exhibit any leak as reported in the complaint.The returned device did however, exhibit filter corrosion, yellowing of hose, wear or removal of the lot identification is externally stamped on the gauge housings, and signs of crazing, all which are indicative of multiple uses of the device.Therefore, the issue reported in this complaint is not confirmed and there are no corrective actions required.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.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2020-00455 and 3008114965-2021-00027.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 on 1/13/2021, the product analysis lab received two (2) trufill dcs syringe ii (635002) contained in one pouch.There are two affixed labels.One is the return order label that has a number ¿2¿ handwritten on it.The second label is the product label for the trufill dcs ii syringe from the lot number (96331357).Follow-up with the korea team confirmed that there were two syringes from the same lot number associated with this complaint.This mdr submission will also include a correction to the manufacturer information in section d.3.A supplemental 3500a report will be submitted once the product investigations have been completed.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2020-00455 and 3008114965-2021-00027.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.Section d.3.Manufacture name: medos international sarl.Manufacturer address line 1: chemin-blanc 38.Manufacture postal code: ch-2400.Manufacture country code: che.

• Brand Name: TRUFILL DCS SYRINGE II
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL.; chemin-blanc 38; le locle neuchatel MA CH-24 00; SZ CH-2400
• MDR Report Key: 10471902
• Report Number: 1226348-2020-00455
• Device Sequence Number: 3344357
• 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): 08/09/2020

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: 96331357
• 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: 08/09/2020
• Supplement Date Received by Manufacturer: 01/13/2021; 01/28/2021
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 01/14/2021; 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRUFILL DCS SYRINGE II