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 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not 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.The photo received with the complaint was visually analyzed.No apparent damage could be appreciated in the picture.The leakage condition could not be noted on the image.The device could be noted on the opened package.A review of manufacturing documentation associated with this lot 96331363 presented no issues during the manufacturing or inspection processes related to the reported complaint.The reported condition ¿cnv syringe- leakage¿ could not be evaluated based on the picture.The mre suggests that the failure reported by the customer could not be related to the manufacturing process.No corrective action will be taken at this time.Further investigation will be performed if the device returns for analysis.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the field, a trufill dcs syringe ii (635002, 96331363) leaks air.It was noted that the syringe couldn't make an unknown coil detached due to the air leakage.The physician switched to a new syringe to complete the procedure.There was no patient injury reported.A picture was provided.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information was received that the trufil dcs syringe was used with a galaxy coil.The galaxy coil was finally implanted in the patient when the syringe was changed.The complaint syringe was not used to deploy any coils prior to this one.The syringe was not able to be pressurized followed by loss of pressure.The device did not take any pressure.No excessive force was applied to the device.No adequate flush had been maintained through the devices.The procedure was prolonged by 10 minutes due to the alleged malfunction.Complaint conclusion: as reported by the field, a trufill dcs syringe ii (635002, 96331363) leaks air.It was noted that the syringe couldn¿t make an unknown coil detached due to the air leakage.The physician switched to a new syringe to complete the procedure.There was no patient injury reported.Additional information was received that the trufil dcs syringe was used with a galaxy coil.The galaxy coil was finally implanted in the patient when the syringe was changed.The complaint syringe was not used to deploy any coils prior to this one.The syringe was not able to be pressurized followed by loss of pressure.The device did not take any pressure.No excessive force was applied to the device.No adequate flush had been maintained through the devices.The procedure was prolonged by 10 minutes due to the alleged malfunction.The device was not returned for analysis, therefore, no further investigation can be performed.The photo received at the time of complaint entry was visually analyzed.No apparent damage could be appreciated in the picture.The leakage condition could not be noted on the image.The device could be noted on the opened package.A review of manufacturing documentation associated with this lot 96331363 presented no issues during the manufacturing or inspection processes related to the reported complaint.With the limited information available and the visual evaluation of the picture received, the reported condition ¿cnv syringe- leakage¿ could not be confirmed.The manufacturing review evaluation (mre) suggests that the failure reported by the customer could not be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices however, it is possible that clinical and procedural factors, including device manipulation/interaction and device selection, may have contributed to the reported issue.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 11193468
• MDR Text Key: 270100720
• Report Number: 3008114965-2021-00034
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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: 96331363
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GALAXY COIL DELIVERY SYSTEM; UNSPECIFIED COIL DELIVERY SYSTEM