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

Model Number	640HX0206
Medical Device Problem Codes	Product Quality Problem (1506); Failure to Advance (2524); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
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.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 left middle cerebral artery aneurysm interventional embolization, the physician was filling the aneurysm with a 2x6 orbit galaxy xtrasoft coil (640hx0206, 30522112).The shape of the coil was not ideal, withdrew the coil outside of the patient¿s body.The surgeon tried to push the coil into the unspecified microcatheter (mc) again, but it became stuck in introducer, could not enter the microcatheter.After several attempts, failed.Switched to another device to complete the surgery.There was not patient injury report.Additional information received indicated that the shape of the coil was not correct or different than expected.The coil failed to conform to the aneurysm wall.It was not necessary to remove the microcatheter.The device did not appear damaged at any time.A continuous flush was maintained.The introducer was flushed until the liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.No excessive force was applied to the device.No other devices were successfully used with the microcatheter prior to the encountered resistance.The concomitant devices functioned as expected.The mc was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.Nothing was obstructing the microcatheter.The device was removed from the patient without additional intervention.There was no significant prolongation in the procedure due to the event.There was no relevant anatomical information including vessel characteristics.
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.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.
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 left middle cerebral artery aneurysm interventional embolization, the physician was filling the aneurysm with a 2x6 orbit galaxy xtrasoft coil (640hx0206, 30522112).The shape of the coil was not ideal, withdrew the coil outside of the patient¿s body.The surgeon tried to push the coil into the unspecified microcatheter (mc) again, but it became stuck in introducer, could not enter the microcatheter.After several attempts, failed.Switched to another device to complete the surgery.There was not patient injury report.Additional information received indicated that the shape of the coil was not correct or different than expected.The coil failed to conform to the aneurysm wall.It was not necessary to remove the microcatheter.The device did not appear damaged at any time.A continuous flush was maintained.The introducer was flushed until the liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.No excessive force was applied to the device.No other devices were successfully used with the microcatheter prior to the encountered resistance.The concomitant devices functioned as expected.The mc was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.Nothing was obstructing the microcatheter.The device was removed from the patient without additional intervention.There was no significant prolongation in the procedure due to the event.There was no relevant anatomical information including vessel characteristics.A non-sterile unit og helical xtrsoft coil 2x6 was received inside of a pouch.The device was visually inspected, and it was noted that the device is in good normal conditions.The og helical xtrsoft coil 2x6 was inspected under microscope and it was found that the embolic coil has the helical shape, however on the surface on some parts of the distal tip of the coil, it was observed what it appears to be some type of damaged.The embolic coil was measured inside the introducer; it was measured 6 cm which indicate that the coil size is correct.Although some kind of damage was observed on the surface of the embolic coil, the embolic coil was advance through the introducer and no resistance/friction was felt during the functional test.A manufacturing investigation was initiated to verify that the manufacturing conditions were adequate.The returned device was analyzed by the manufacturing team to determine the potential cause of not well-defined coil shape and damaged.A physical analysis of the coil shape was performed using a microscope.The following characteristics were found: 1.The coil keeps a helical shape.2.Does have a well-defined center.3.Visually, all loops are the same size.4.Loops are tightly packed.The characteristics found in the received unit give us a clear indicator that the coil is well defined as a typical helical shape.In addition, per procedure, (coil is kinked stretched or damaged), (damaged coil inside introducer), which show the possible damages that may occur during the manufacturing process, it was not found a type of damage that resembles the one.A manufacturing record evaluation (mre) was performed for the finished device 30522112 number, and no non-conformances related to the malfunction were identified.In conclusion, based on the controls along the manufacturing process to inspect the shape and damaged coil inside introducer according to catalog specification, it was confirmed by the manufacturing team that the coil is classified as helical shape according with characteristics found and the damaged could have not been originated during the manufacturing process.Cerenovus conducted visual inspection, microscopic, dimensional inspection and functional test.During the visual analysis of the device, no damages or anomalies were observed.Then a microscope investigation was performed, and it was noted that the embolic coil has the helical shape, however on the surface on some parts of the distal tip of the coil, it was observed what it appears to be some type of damaged.Procedural factors may contribute to the finding; however, this cannot be conclusively determined.The customer complaint regarding a ¿coil - positioning difficulty-poor conformability¿ could not be evaluated since it is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab.However, the damaged noted on the surface could be related with the customer experience at the procedure time.Due this condition the customer complaint was confirmed.A manufacturing record evaluation (mre) and a device history record (dhr) were performed, and no non-conformances or issues related to the reported complaint condition were identified during the review.It should be noted that product failure is multifactorial.The instructions for use (ifu) do contain the following precautions: the detachable coils are delicate and must be handled carefully.Prior to use and when possible, during the procedure, inspect the system for bends or kinks.Do not use a coil system showing signs of damage.* ensure proper detachable coil selection according to vascular territory and measurements taken from a baseline angiogram.Assignment of root cause for the events 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 cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.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 events were 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: 12408137
• Report Number: 3008114965-2021-00441
• Device Sequence Number: 19879083
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2021

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: 01/31/2023
• Device Model Number: 640HX0206
• Device Catalogue Number: 640HX0206
• Device Lot Number: 30522112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/01/2021; 10/22/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/17/2021; 10/25/2021
• 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: UNSPECIFIED MICROCATHETER