MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3X8; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0308
Medical Device Problem Codes	Separation Problem (4043); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Procode: krd/hcg the device was discarded; therefore, no product investigation can be performed.A manufacturing record evaluation was performed for the finished device 30103629 number, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
As reported by the field, during an endo-vascular coiling, when putting a 3x8 og cmplx xtrasoft coil (640cx0308, 30103629) in the aneurysm, the catheter came out.The user tried to push it in the aneurysm but in the manipulation of the coil, and catheter and the coil ¿broke¿.The coil was taken out with difficulty.There was a procedural delay by one hour due to the event.The procedure was successfully completed.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Updated sections on this report and concomitant products.Section b5: additional information / clarification received indicated that the coil prematurely detached at the detachment zone of the delivery tube.There was no report of a clinically significant delay due to the event.The delay was due to the coil becoming stuck with the prowler lpes 14 microcatheter (mc).The coil was removed by the ¿help of the micro catheter¿.The concomitant devices functioned as expected.The mc was necessary to be removed with the coil delivery system as the coil prematurely detached in the mc, hence necessary to remove the microcatheter.No excessive force was applied to the device.Prior to this coil, other coils had been able to be advanced through the same microcatheter.No coils had been previously implanted.There was no resistance / friction between the coil and the mc when ¿putting the coil in the aneurysm¿.The procedure was to the anterior communicating artery (acomm).The site was 3mmx2mmx2mm.Section h6 - device codes: updated to ¿premature separation¿.Based on additional event information, the device code of ¿separation¿ is no longer applicable.Complaint conclusion: as reported by the field, during an endo-vascular coiling, when putting a 3x8 og cmplx xtrasoft coil (640cx0308, 30103629) in the aneurysm, the catheter came out.The user tried to push it in the aneurysm but in the manipulation of the coil, and catheter and the coil ¿broke¿.The coil was taken out with difficulty.There was a procedural delay by one hour due to the event.The procedure was successfully completed.There was no patient injury reported.Additional information / clarification received indicated that the coil prematurely detached at the detachment zone of the delivery tube.There was no report of a clinically significant delay due to the event.The delay was due to the coil becoming stuck with the prowler lpes 14 microcatheter (mc).The coil was removed by the ¿help of the micro catheter¿.The concomitant devices functioned as expected.The mc was necessary to be removed with the coil delivery system as the coil prematurely detached in the mc, hence necessary to remove the microcatheter.No excessive force was applied to the device.Prior to this coil, other coils had been able to be advanced through the same microcatheter.No coils had been previously implanted.There was no resistance / friction between the coil and the mc when ¿putting the coil in the aneurysm¿.The procedure was to the anterior communicating artery (acomm).The site was 3mmx2mmx2mm.The device was not returned for analysis; therefore, no product investigation can be performed.A manufacturing record evaluation was performed for the finished device 30103629 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil - positioning difficulty¿ and ¿coil - premature detachment-during placement¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The instructions for use (ifu) instructs that under fluoroscopy, deploy the detachable coil by carefully pushing the delivery tube into the proximal end of the second rhv.Continue pushing the delivery tube to position the coil within the desired vascular location.Hold the infusion catheter body in place while the coil is delivered to prevent the infusion catheter tip from moving from its intended position.The ifu cautions that repositioning the infusion catheter while the coil is deployed can lead to damage and/or premature detachment of the coil.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Based on the information available, the microcatheter kicked back, which could have contributed to the events.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 CMPLX XTRASOFT COIL 3X8
• 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: 10244845
• Report Number: 3008114965-2020-00277
• Device Sequence Number: 16292334
• Product Code: KRD
• UDI-Device Identifier: 10886704030607
• UDI-Public: 10886704030607
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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: 06/30/2020
• Device Model Number: 640CX0308
• Device Catalogue Number: 640CX0308
• Device Lot Number: 30103629
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/04/2020
• 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: PROWLER SELECT LPES 45 DEG TIP