MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3.5X9; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX3509
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.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.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.This is one of five products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00425, 3008114965-2020-00426, 3008114965-2020-00428, and 3008264254-2020-00004.
Event or Problem Description
As reported by the field, during a coil embolization of a cerebral artery aneurysm, four coils, a 5x10 og tdl cmplx fill (640cf0510, 30132962), a 7x25 og tdl cmplx frame (640cr0725, 30374735), a 4x12 og tdl cmplx fill (640cf0412, 30348520) and a 3.5x9 og cmplx xtrasoft (640cx3509, 30282523) became stuck inside the hub of a prowler select14 microcatheter (product/lot number unknown).The coils ¿never went passed the microcatheter hub.¿ therefore, the microcatheter (mc) never entered the patient¿s intracranial space.The microcatheter was replaced resulting in loss of cerebral target positioning along with the four coils.The procedure was successfully completed with the replacement microcatheter and replacement coils.These coils were not implanted in the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Section b5: additional information/clarification was received that the og tdl cmplx fill coil 5x10 (640cf0510, 30132962) previously reported under this complaint belongs to another complaint.Complaint conclusion: as reported by the field, during a coil embolization of a cerebral artery aneurysm, three coils, a 7x25 og tdl cmplx frame (640cr0725, 30374735), a 4x12 og tdl cmplx fill (640cf0412, 30348520) and a 3.5x9 og cmplx xtrasoft (640cx3509, 30282523) became stuck inside the hub of a prowler select 14 microcatheter (product/lot number unknown).The coils ¿never went past the microcatheter hub.¿ therefore, the microcatheter (mc) never entered the patient¿s intracranial space.The microcatheter was replaced resulting in loss of cerebral target positioning along with the three coils.The procedure was successfully completed with the replacement of a microcatheter and the coils were replaced.These coils were not implanted in the patient.A non-sterile unit og cmplx xtrasoft coil 3.5x9 was received inside of a pouch.The device was inspected, and it was found in good normal conditions, no damages or anomalies were observed during the visual inspection.The embolic coil was inspected under a microscope and it was found stuck inside the introducer with a damage condition.The functional analysis could not be performed due to the stuck and damaged condition noted on the embolic coil.A manufacturing record evaluation was performed for the finished device 30282523 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿detachable coil delivery system (dcs) - impeded in microcatheter with loss of cerebral target position¿ could not be evaluated, during the analysis it was noted that the embolic coil was stuck inside the introducer with a damage condition.This condition could be related to the customer¿s experience and appear to may have been caused by excessive force and handling being applied to the device, however, none of those can be conclusively determined.Based on the information obtained during the analysis, the customer's complaint can be confirmed.Neither the analysis nor the mre suggests that the failure reported by the customer could be related to the manufacturing process.The instructions for use (ifu) warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.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 events were 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: OG CMPLX XTRASOFT COIL 3.5X9
• 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: 10573575
• Report Number: 3008114965-2020-00429
• Device Sequence Number: 13773607
• Product Code: KRD
• UDI-Device Identifier: 10886704030690
• UDI-Public: 10886704030690
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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: 07/31/2021
• Device Model Number: 640CX3509
• Device Catalogue Number: 640CX3509
• Device Lot Number: 30282523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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: OG TDL CMPLX FILL COIL 4X12.; OG TDL CMPLX FILL COIL 5X10.; OG TDL CMPLX FRAME COIL 7X25.; UNKPROWLERSELECT.; OG TDL CMPLX FILL COIL 4X12; OG TDL CMPLX FILL COIL 5X10; OG TDL CMPLX FRAME COIL 7X25; UNKPROWLERSELECT