MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG HELICAL XTRSOFT COIL 2X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640HX0206
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
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.Procode: krd/hcg.Initial reporter phone: (b)(6).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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, during a stent-assisted aneurysm embolization, a 2x6 og helical xtrsoft coil (640hx0206, 30286061) couldn't be detached.There was leakage in the joint between the coil body and puller rod.The physician withdrew the coil outside of the patient¿s body.Changed to another new coil to complete the procedure.There was no patient injured reported.Additional information indicated that pre-deployment electrical testing was not performed.The same detachable control box (dcb) was used successfully with subsequent coils and the same cable was also used successfully with subsequent coils.The coil was still attached to the coil delivery system when removed from the patient.The actual coil was not stretched or damaged when removed.There was no prepping difficulty.No excessive force was applied to the device.It was necessary to remove concomitant devices with the complaint device.Adequate flush was been maintained through the devices.The event prolonged the procedure by 10 minutes.
Additional Manufacturer Narrative
Product complaint # (b)(4).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, a 2x6 og helical xtrsoft coil (640hx0206, 30286061) couldn't be detached.There was leakage in the joint between coil body and puller rod.The physician withdrew the coil outside of the patient¿s body.Changed to another new coil to complete the procedure.There was no patient injured reported.Additional information indicated that pre-deployment electrical testing was not performed.The same detachable control box (dcb) was used successfully with subsequent coils and the same cable was also used successfully with subsequent coils.The coil was still attached to the coil delivery system when removed from the patient.The actual coil was not stretched or damaged when removed.There was no prepping difficulty.No excessive force was applied to the device.It was necessary to remove concomitant devices with the complaint device.Adequate flush was been maintained through the devices.The event prolonged the procedure by 10 minutes.A non-sterile unit og helical xtrsoft coil 2x6 was received inside of a pouch.The device was inspected, and it was found the hypo-tube is several kinked, no other damages or anomalies were observed on it.The embolic coil was inspected under microscope and it was found with a stretch condition.The functional test could not be performed due the several kinked conditions noted on the hypo-tube and the stretched condition noted on the embolic coil.A manufacturing record evaluation was performed for the finished device 30286061 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil ¿ failure to detach¿ could not be duplicated, during the analysis, it was noted that the hypo-tube has several kinked conditions, also, the embolic coil has a stretch condition.These conditions could be related with the customer¿s complaint and may appear to might have been caused by excessive force and/or handling applied to the device, however the exact time when these conditions appeared could not conclusively determine.Neither the analysis nor the mre suggests that the failure reported by the customer could be related to the manufacturing process.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.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.

• Brand Name: OG HELICAL XTRSOFT COIL 2X6
• 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: 10785623
• Report Number: 3008114965-2020-00498
• Device Sequence Number: 19867178
• Product Code: KRD
• UDI-Device Identifier: 10886704030720
• UDI-Public: 10886704030720
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 640HX0206
• Device Catalogue Number: 640HX0206
• Device Lot Number: 30286061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1