MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 4X12; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0412
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular coil embolization procedure, it was reported that the 4mm x 12cm orbit galaxy complex fill coil (640cf0412 / 30596904) made a helical shape even though this coil is not supposed to form this shape.After this issue was detected during the procedure monitoring step, the physician retracted the coil and fully removed it from the patient.There was no procedure delay due to the reported event.The procedure was reported as successfully completed.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / 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.A review of manufacturing documentation associated with this lot (30596904) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 12-apr-2022.[additional information]: on 12-apr-2022, additional information was received.The information indicated that the target was a 4mm saccular shape anterior communicating artery (acom) aneurysm.Procedure images showing the shape of the coil while inside the target aneurysm is not available.Photos of the coil when it was removed from the patient are also not available.Photo of the product label is also not available; the original packaging was discarded.The concomitant microcatheter used was an excelsior® sl-10® microcatheter (stryker).Information related to the replacement coil is not available.E.1: initial reporter phone: (b)(6).Updated sections: b.4, e.1, g.3, g.6, h.2, h.10, and concomitant products.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received the product analysis lab on 07-apr-2022.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an endovascular coil embolization procedure, it was reported that the 4mm x 12cm orbit galaxy complex fill coil (640cf0412 / 30596904) made a helical shape even though this coil is not supposed to form this shape.After this issue was detected during the procedure monitoring step, the physician retracted the coil and fully removed it from the patient.There was no procedure delay due to the reported event.The procedure was reported as successfully completed.There was no report of any patient adverse event or complication.On 12-apr-2022, additional information was received.The information indicated that the target was a 4mm saccular shape anterior communicating artery (acom) aneurysm.Procedure images showing the shape of the coil while inside the target aneurysm is not available.Photos of the coil when it was removed from the patient are also not available.Photo of the product label is also not available; the original packaging was discarded.The concomitant microcatheter used was an excelsior® sl-10® microcatheter (stryker).Information related to the replacement coil is not available.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 4mm x 12cm orbit galaxy complex fill coil was received.Upon receiving the device, a visual inspection was performed.All components were observed to be in good condition.The embolic coil component is inside the introducer.The coil component was measured to verify if the coil size matched the label specification, and the length was confirmed to measure 12 cm.Under microscopic magnification, no damages were noted on the embolic coil (i.E., no kinks, elongations, or non-concentric loops).The embolic coil was extended to analyze its horizontal shape, and three (3) consecutive coils near its proximal end (i.E., near the headpiece) seemed to take a helical shape.Near its distal end, the embolic coil was noted to be slightly extended, presumably due to the retraction to the introducer to remove it from the patient.The embolic coil was also vertically deployed to analyze its axial view, and the same three (3) loops were noted to have similar diameters.The embolic coil was soaked in lukewarm water and inspected again under magnification.This time, the loop that had been observed extended near the distal end was noted to be contracted, the original shape of the embolic coil was restored, all the loops seemed to be contained within the embolic coil diameter.The conditions noted above were compared against the manufacturing visual standards.The following characteristics shall be met but were not observed on the complaint coil: 1.In order to consider that an embolic coil has a complex shape, the embolic coils with a diameter of 3 mm, 3.5 mm, and 4 mm must have at least one loop crossing the center, or the loop has to have a void on both sides of it.A helical shape where the loops do not maintain a consistent diameter must be rejected.2.Helical shape coils must maintain a helical shape from the distal end all the way to the solder junction at the headpiece and it must be visually inspected using the adequate tool.There were three (3) loops of the complaint coil that seemed to take a helical shape; however, subsequent loops are clearly noted to have irregular shapes that are consistent with the complex coil.It is possible that these three (3) consecutive loops observed at the proximal end of the embolic coil might have misled the physician about the coil shape.With the information currently available, this cannot be conclusively determined.The characteristics found in the received unit gave an indication that the coil is not helical-shaped, as reported in the event description; however, the assumption that the coil might have an incorrect shape could have been based on factors not described in the event description and that could not be replicated in the lab.The customer complaint was not confirmed.A review of manufacturing documentation associated with this lot (30596904) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.H.6: investigation findings / investigation conclusions: the ¿no device problem found¿ code was used in the investigational findings because based on the investigation performed on the returned complaint product, there were three (3) loops of the complaint coil that seemed to take a helical shape; however, subsequent loops are clearly noted to have irregular shapes that are consistent with the complex coil.It is possible that these three (3) consecutive loops observed at the proximal end of the embolic coil might have misled the physician about the coil shape.The characteristics found in the received unit gave an indication that the coil is not helical-shaped, as reported in the event description; however, the assumption that the coil might have an incorrect shape could have been based on factors not described in the event description and that could not be replicated in the lab.The customer complaint was not confirmed.This code corresponds to the code ¿cause not established¿ code in the investigation conclusions.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: OG TDL CMPLX FILL COIL 4X12
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: michelleann garcia ; 31 technology dr.; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 13953849
• Report Number: 3008114965-2022-00204
• Device Sequence Number: 17335356
• Product Code: KRD
• UDI-Device Identifier: 10886704030270
• UDI-Public: 10886704030270
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/06/2022

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: 05/31/2023
• Device Model Number: 640CF0412
• Device Catalogue Number: 640CF0412
• Device Lot Number: 30596904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 03/16/2022; 04/12/2022; 06/06/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 04/07/2022; 04/12/2022; 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR® SL-10® MICROCATHETER (STRYKER).
• Patient Sex: Unknown