MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 2X2; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0202
Medical Device Problem Codes	Material Separation (1562); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization, angiography confirmed the female patient experienced an anterior communicating artery aneurysm.The prowler select lpes (606s155x, 30503118) microcatheter (mc) arrived at the upper third of the aneurysm, the physician filled the aneurysm with a coil smoothly and then filled a second coil successfully again.Angiography confirmed that there was no dense embolism.Then a 2x2 orbit galaxy xtrasoft coil (640cx0202, 30526759) was selected as the last filling coil.Since there was a little space left in the tumor for the first-time delivery, the physician attempted several times for adjusting.The coil still could not fill the aneurysm completely, the doctor retracted the coil and tried to adjust.After repeated deliveries, the delivery wire of the stent broke into two parts.The coil was retracted, and a new coil was used to complete the surgery.There was no patient injury reported.Additional information received indicated that there was difficulty getting the coil to conform to the aneurysm wall.The coil appears to be a different coil wind than expected.The coil did not appear to be damage while in the aneurysm which could have contributed to the positioning difficulty.The aneurysm characteristics may have contributed to the positioning difficulty.The coil did not become unraveled/stretched.There was no blood flow restriction/reduction as a result of the event.An adequate flush was maintained through the devices.There was no procedural delay due to the event.Two pictures of the device were received.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).According to the photos provided by the customer, it can be visually observed that the hypo-tube is broken into two parts.The coil could be noted outside from the introducer, still attached to the device and with a kinked condition, this damage condition may contribute to the irregular shape noted in the coil.No other damages can be appreciated in the photos.A manufacturing record evaluation was performed for the finished device 30526759 number, and no non-conformances related to the malfunction were identified.The customer complaint was confirmed.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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 coil embolization, angiography confirmed the female patient experienced an anterior communicating artery aneurysm.The prowler select lpes (606s155x, 30503118) microcatheter (mc) arrived at the upper third of the aneurysm, the physician filled the aneurysm with a coil smoothly and then filled a second coil successfully again.Angiography confirmed that there was no dense embolism.Then a 2x2 orbit galaxy xtrasoft coil (640cx0202, 30526759) was selected as the last filling coil.Since there was a little space left in the tumor for the first-time delivery, the physician attempted several times for adjusting.The coil still could not fill the aneurysm completely, the doctor retracted the coil and tried to adjust.After repeated deliveries, the delivery wire of the stent broke into two parts.The coil was retracted, and a new coil was used to complete the surgery.There was no patient injury reported.Additional information received indicated that there was difficulty getting the coil to conform to the aneurysm wall.The coil appears to be a different coil wind than expected.The coil did not appear to be damage while in the aneurysm which could have contributed to the positioning difficulty.The aneurysm characteristics may have contributed to the positioning difficulty.The coil did not become unraveled/stretched.There was no blood flow restriction/reduction as a result of the event.An adequate flush was maintained through the devices.There was no procedural delay due to the event.Two pictures were attached to the complaint file in which it can be observed that the hypo-tube is broken into two parts.The coil was tried to be evaluated however, due to the resolution of the photo, it is difficult to determine if the coil has any damage that has contributed to the difficulty of positioning.No other abnormalities can be appreciated in the photos.A manufacturing record evaluation was performed for the finished device 30526759 number, and no non-conformances related to the malfunction were identified.The device was returned to cerenovus for further evaluation.A non-sterile og cmplx xtrasoft coil 2x2 was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the hypo-tube was broken in two parts, as seen in the pre-shipment pictures.No other damages were noted in the device.The device was inspected under microscopic magnification, and it was found that the embolic coil is in good normal conditions (i.E., no elongations, kinks, or non-concentric loops were noted).Due to the broken condition noted on the hypo-tube a scanning electron microscope (sem) testing was performed, and the results are as follows: the images show evidence of mechanical damage and stress marks on the hypo-tube.These damages could be related to the handling of the device during the procedure or excessive force; however, this cannot be conclusively determined.No other anomalies were observed.The complaint documented that the physician tried to readjust the position of the coil repeated times, and after repeated deliveries, the hypo-tube broke into two parts; at trying to readjust the coil multiple times might have caused some force to be inadvertently exerted on the device, which can result on the hypo-tube damage.Based on these findings, the customer complaint regarding a delivery tube separated-during use was able to be confirmed.The customer complaint regarding positioning difficulty could not be confirmed since the reported issue is specific to the patient and procedure at the time of occurrence and cannot be replicated in the laboratory.However, positioning difficulty is a known potential issue associated with the use of the device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: failure to open the second rhv sufficiently prior to slow and careful removal of the delivery tube from the patient could result in damage to the distal portion of the delivery tube.If coil repositioning is required, gently withdraw and then re-advance the coil.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h10.The product has been returned for evaluation and testing.However, the engineering evaluation has not been completed.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 2X2
• 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: 14655141
• Report Number: 3008114965-2022-00413
• Device Sequence Number: 5109498
• Product Code: KRD
• UDI-Device Identifier: 10886704030546
• UDI-Public: 10886704030546
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/22/2022

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: 01/31/2023
• Device Model Number: 640CX0202
• Device Catalogue Number: 640CX0202
• Device Lot Number: 30526759
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 06/16/2022; 07/19/2022; 08/18/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 06/16/2022; 08/01/2022; 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2021
• 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: PROWLER SELECT LPES.
• Patient Sex: Female