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

Model Number 635-002

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

(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 96331359 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 Description

The healthcare professional reported that when the trufill dcs syringe ii (635002 / 96331359) was being prepped with saline, a leak was found on the syringe.It was reported that the procedure was not delayed due to the reported event; it was successfully completed.There was no report of any patient adverse event or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to report that the final investigation of the complaint device has been completed by the original equipment supplier atrion medical.[conclusion]: the healthcare professional reported that when the trufill dcs syringe ii (635002 / 96331359) was being prepped with saline, a leak was found on the syringe.It was reported that the procedure was not delayed due to the reported event; it was successfully completed.There was no report of any patient adverse event or complication.Additional information was received on 10 april 2021.The information confirmed that the saline leak occurred during the device prep.There was no crack on the device.The syringe pressure was taken to the green zone before the leak was noticed.The syringe was securely connected directly to the hub of the delivery tube.The leak prevented the pressurization of the syringe.It was also reported that the leak did also occur during the purging of the coil system for the blue zone.Another syringe was used to complete the procedure.On 22 april 2021, additional clarification information was received indicating that the complaint device was not used to detach the coil; it was replaced with another trufill device.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the device was received and sent to the original equipment supplier / manufacturer for investigation and the results are shown below.Visual inspection: it was noted that the gauge needle was in the zero position when received.The gauge face was warped / distorted on the lower right-hand side.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.There were cracks and crazing on various areas of the device.Functional evaluation: 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, water began to leak and spray from the top of the housing.The gauge attempted to respond, but the profuse leaking prevented adequate pressure from building for full functional testing.Therefore, functional testing was discontinued.A review of manufacturing documentation associated with this lot 96331359 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 complaint device exhibits the cts mark indicating 100% functionality at time of manufacturing.Additionally, the gauge face was distorted/warped in the lower right-hand area indicative of exposure to excessive heat.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.The crazing, cracking, warped gauge face, and worn or removed gauge lot identification, all are indicative of multiple use of the device.Therefore, this complaint is not confirmed and there are no corrective actions required.As a reminder, 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.Updated sections: 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.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to include the additional event information received on 10 april 2021, 22 april 2021 and that the product analysis lab received the complaint device on 21 april 2021.E.1: initial reporter phone: (b)(6).[additional information]: the healthcare professional reported that when the trufill dcs syringe ii (635002 / 96331359) was being prepped with saline, a leak was found on the syringe.It was reported that the procedure was not delayed due to the reported event; it was successfully completed.There was no report of any patient adverse event or complication.Additional information was received on 10 april 2021.The information confirmed that the saline leak occurred during the device prep.There was no crack on the device.The syringe pressure was taken to the green zone before the leak was noticed.The syringe was securely connected directly to the hub of the delivery tube.The leak prevented the pressurization of the syringe.It was also reported that the leak did also occur during the purging of the coil system for the blue zone.Another syringe was used to complete the procedure.On 22 april 2021, additional clarification information was received indicating that the complaint device was not used to detach the coil; it was replaced with another trufill device.The device was received by the product analysis lab on 21 april 2021.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: d.9, e.1, 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
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11582311
• MDR Text Key: 280508823
• Report Number: 3008114965-2021-00117
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704029410
• UDI-Public: 10886704029410
• Combination Product (y/n): N
• PMA/PMN Number: K063254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 635-002
• Device Catalogue Number: 635002
• Device Lot Number: 96331359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1