MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL10 4MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF100408
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
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: 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.(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
A report from the field indicated that during a coil embolization of a ruptured cerebral aneurysm, a 4mm x 8cm deltafill10 (dlf100408/l16128) coil could only be introduced into the unspecified microcatheter ¿a little bit¿.Then, the coil was pulled back a little and readvanced.During readvancement, the re-sheathing tool detached distally from the green insertion tool.Thus, the device positioning unit (dpu) wire formed a loop within the white protective coil sheath.The patient was acutely bleeding, so the physician retrieved the coil quickly and changed for another one.The other coils were successfully advanced through the microcatheter to complete the procedure.The consequent delay in procedure reportedly worsened the patient¿s outcome since bleeding was acute and intracranial hemorrhage increased.It was further stated that the coil exchange prolonged the procedure and thus decreased chances of good patient outcome.Other coils had to be used; therefore, there was increased x-ray exposure to the patient and physicians.The current health status of the patient is unknown.The complaint coil will be returned for evaluation.No further information was provided at the time of complaint initiation.
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.Section b5: additional information received on 02 jul 2021 indicated that the coil became stuck in the proximal shaft of the non-cerenovus microcatheter (brand not specified).The reported issue did not require removal of the microcatheter with subsequent loss of cerebral target position.The same microcatheter was used to complete the procedure.The physician confirmed that the aneurysm was ruptured at baseline.It is not known whether there was any damage to the actual embolic coil; the coil was not visually inspected.Information regarding the length of procedural delay (# of minutes), total duration of the procedure, target aneurysm location, pre-and post-hunt & hess scores, and current health status of the patient was not provided.Anonymized procedural imaging/films are not available for review.
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).Updated sections on this medwatch report: g3, g6, h2, h3, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: a report from the field indicated that during a coil embolization of a ruptured cerebral aneurysm, a 4mm x 8cm deltafill10 (dlf100408/l16128) coil could only be introduced into the unspecified microcatheter ¿a little bit¿.Then, the coil was pulled back a little and readvanced.During readvancement, the re-sheathing tool detached distally from the green insertion tool.Thus, the device positioning unit (dpu) wire formed a loop within the white protective coil sheath.The patient was acutely bleeding, so the physician retrieved the coil quickly and changed for another one.The other coils were successfully advanced through the microcatheter to complete the procedure.The consequent delay in procedure reportedly worsened the patient¿s outcome since bleeding was acute and intracranial hemorrhage increased.It was further stated that the coil exchange prolonged the procedure and thus decreased chances of good patient outcome.Other coils had to be used; therefore, there was increased x-ray exposure to the patient and physicians.The current health status of the patient is unknown.Additional information received on 02 jul 2021 indicated that the coil became stuck in the proximal shaft of the non-cerenovus microcatheter (brand not specified).The reported issue did not require removal of the microcatheter with subsequent loss of cerebral target position.The same microcatheter was used to complete the procedure.The physician confirmed that the aneurysm was ruptured at baseline.It is not known whether there was any damage to the actual embolic coil; the coil was not visually inspected.Information regarding the length of procedural delay (# of minutes), total duration of the procedure, target aneurysm location, pre-and post-hunt & hess scores, and current health status of the patient was not provided.Anonymized procedural imaging/films are not available for review.A non-sterile deltafill10 4mm x 8cm was received for analysis at cerenovus, the device was inspected, and it was found that the core wire is kinked and protruded from introducer, no other damages or anomalies were observed during the visual analysis.The device was inspected under a microscope and it was found that the embolic coil is in good normal condition.A functional test could not be performed due to the core wire is kinked and protruded from introducer.A manufacturing record evaluation (mre) was performed for the finished device l16128 number, and no non-conformances related to the reported complaint condition were identified.Cerenovus conducted a visual inspection and microscopic examination of the returned device.A functional test could not be performed due to the conditions in which the device was returned.The visual analysis of the returned sample determined that the core wire is kinked and protruded from introducer.A microscopic test was performed, and it was found that the embolic coil is in good normal conditions.The customer complaints regarding ¿detachable coil delivery system (dcs) - impeded in microcatheter with no loss of cerebral target position¿ and ¿device positioning unit - kinked/bent¿ were confirmed since during the analysis the core wire was noted kinked and protruded from introducer, these conditions could be the result of the impeded experience at the procedure time.However, this cannot conclusively determine.Based on the findings during the analysis, the customer complaint was confirmed.The customer complaint regarding ¿coil introducer - separated-during use¿ was not confirmed, since during the analysis the introducer was found on its place.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure is multifactorial.Although no conclusion could be reach on the cause of the reported events, the instructions for use (ifu) contain the following recommendations: ¿ if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.After flushing, reinsert the introducer into the infusion catheter hub as described in ¿microcoil placement¿ section above.If unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.If repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.¿ if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.Pulling the exposed microcoil through the rhv grommet may damage the coil.Impeded in microcatheter, introducer separated, and dpu kinked/bent are known complications associated with the use of the deltafill10 coil in coil embolization procedures.With the information provided, it is not possible to determine the root cause of the event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.Based on the physician report that the coil exchange resulted in a clinically significant procedural delay with increased intracranial bleeding (from baseline) as the reported outcome.The file will be re-reviewed if additional information is received at a later date.As part of the 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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: DELTAFILL10 4MM X 8CM
• 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: 12084568
• Report Number: 3008114965-2021-00268
• Device Sequence Number: 17233005
• Product Code: KRD
• UDI-Device Identifier: 10886704077060
• UDI-Public: 10886704077060
• Combination Product (Y/N): N
• PMA/510(K) Number: K150319
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: DLF100408
• Device Catalogue Number: DLF100408
• Device Lot Number: L16128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/02/2021; 08/10/2021; 09/01/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/23/2021; 08/25/2021; 09/02/2021
• 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