MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MECHANICAL DETACHMENT HANDLE; CEREPAK DETACHABLE COIL SYSTEM

Model Number MDH1

Device Problems Difficult to Insert (1316); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00372.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

It was reported that a 53-year-old female patient underwent an endovascular embolization procedure to treat a middle internal carotid artery (ica) tortuosity aneurysm.Per event description, ¿the coil became stuck in the detachment device.¿ it was then unstuck but then the coil did not detached properly.It was further stated that ¿it seemed as if the stretch resistant wire held on and stayed connected to the coils after actuation of the detachment device failed.¿ additional clarification was collected stating that ¿two loops of coil deployed in aneurysm¿, then a ¿fred flow diverter was deployed, jailing the microcatheter (which took about 30-40 minutes), thus then being able to fully deploy the coil into the aneurysm.It was mentioned that at this point, ¿coil detachment was attempted with detacher¿ and that because ¿proximal hypotube was stuck in detacher¿ this has been pulled form the detacher.¿a manual break was attempted and pulled, and the inner pull wire broke¿.Coil detachment was attempted unsuccessfully with kelly forceps.Because coil was still attached, the coil was pulled out, pushed back in for 3-times and eventually it detached in the aneurysm.The procedure was finished with stryker coils.It was further referred that patient presented a ¿very complex, anatomy, 90-degree bend at the proximal ica / distal petrous, vessel was down, straight up and stenotic at vent.At the syphon the vessel performed the same way with less stenosis¿.It is unknown if continuous flush has been performed no further information was provided at the time of complaint initiation.

Manufacturer Narrative

Product complaint # (b)(4) complaint conclusion: it was reported that a 53-year-old female patient underwent an endovascular embolization procedure to treat a middle internal carotid artery (ica) tortuosity aneurysm.Per event description, ¿the coil became stuck in the detachment device.¿ it was then unstuck but then the coil did not detached properly.It was further stated that ¿it seemed as if the stretch resistant wire held on and stayed connected to the coils after actuation of the detachment device failed.¿ additional clarification was collected stating that ¿two loops of coil deployed in aneurysm¿, then a ¿fred flow diverter was deployed, jailing the microcatheter (which took about 30-40 minutes), thus then being able to fully deploy the coil into the aneurysm.It was mentioned that at this point, ¿coil detachment was attempted with detacher¿ and that because ¿proximal hypotube was stuck in detacher¿ this has been pulled form the detacher.¿a manual break was attempted and pulled, and the inner pull wire broke¿.Coil detachment was attempted unsuccessfully with kelly forceps.Because coil was still attached, the coil was pulled out, pushed back in for 3-times and eventually it detached in the aneurysm.The procedure was finished with stryker coils.It was further referred that patient presented a ¿very complex, anatomy, 90-degree bend at the proximal ica / distal petrous, vessel was down, straight up and stenotic at vent.At the syphon the vessel performed the same way with less stenosis¿.It is unknown if continuous flush has been performed no further information was provided at the time of complaint initiation.A non-sterile mechanical detachment handle was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and no appearance of damages were observed.The housing clips and cone were noted to be fully engaged.The cone was found locked in place.A functional testing was performed in which the slider was noted to easily translate when activated.A click was audibly heard upon completion of the actuation.The slider was noted to automatically recover from the starting position after actuation, and an audibly click was heard upon completing of reset.The proximal end of a cerepak coil delivery system was easily inserted into the nose cone.The handle slider was noted to travel full distance, and the proximal inner tube travel distance was 13 mm.The slider and shuttle assembly were found fully engaged.The nose cone was removed while keeping the housing intact, a visual inspection was performed, and the components were found in normal position, clean with no appearance of damages.A dimensional analysis was performed, and all measurements were found within specifications.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issues reported regarding the failure of the mechanical detacher could not be confirmed with the evidence available.It is possible that other clinical and procedural factors that cannot be replicated during the analysis may have contributed to the reported failure.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.Since no issues were identified, no capa activity is required.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: 1.Remove the detacher from the protective packaging and place it within the sterile field.The detacher is packaged separately for single patient use only.2.Confirm again under fluoroscopy that the coil alignment marker of the delivery tube creates a ¿t¿ with the proximal marker of the microcatheter.3.Verify that the rhv is firmly locked around the delivery tube to ensure that the coil does not move during connection process.Ensure the delivery tube is straight between the rhv and the detacher.4.Hold the delivery tube approximately 3 inches from proximal end and bring the detacher over the delivery tube until a firm stop is felt.5.Maintain the delivery tube position within the detacher and use a thumb to pull back the slider on the detacher.6.Continue to pull on the slider until end of travel or a click is heard.Gently release the slider until it returns to starting position or a second click is heard.Remove detacher by slowly withdrawing it from the delivery tube.Note: detacher must remain in sterile field until the procedure is completed.7.Fluoroscopically verify that the coil is detached by gently pulling back the delivery tube approximately 1cm.If the coil has detached, remove the delivery tube from the microcatheter.8.If the coil has not detached, repeat steps 3-7.If 2 unsuccessful detachments occur, discard the detacher and proceed to the manual break section.9.Repeat steps 1-8 until the procedure is completed.Discard the detacher.Caution: always perform fluoroscopic verification of detachment prior to withdrawing the delivery system fully.Failure to do so may lead to an embolic complication.10.After detaching the coil, remove the delivery tube from the microcatheter and discard.11.Repeat the above sequence for all additional coils until the procedure is complete.The cerepak ifu states that a backup detacher is suggested for all procedures.The ifu also states that the user should: ¿verify that the rhv is firmly locked around the delivery tube to ensure that the coil does not move during connection process.Ensure the delivery tube is straight between the rhv and the detacher.Hold the delivery tube approximately 3 inches from proximal end and bring the detacher over the delivery tube until a firm stop is felt.Maintain the delivery tube position within the detacher and use a thumb to pull back the slider on the detacher.Continue to pull on the slider until end of travel or a click is heard.Gently release the slider until it returns to starting position or a second click is heard.Remove detacher by slowly withdrawing it from the delivery tube.It further states that if 2 unsuccessful detachments occur, discard the detacher and proceed to manual break.Although the detacher mechanism could not be actuated and required the use of manual break and/or additional coil manipulation the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote thus the event does not meet usfda mdr reporting criteria under 21 cfr 803 and will be processed accordingly.The file will be re-reviewed if additional information is received at a later date.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.

Manufacturer Narrative

Product complaint #: (b)(4).The cerepak ifu states that a backup detacher is suggested for all procedures.The ifu also states that the user should: ¿verify that the rhv is firmly locked around the delivery tube to ensure that the coil does not move during connection process.Ensure the delivery tube is straight between the rhv and the detacher.Hold the delivery tube approximately 3 inches from proximal end and bring the detacher over the delivery tube until a firm stop is felt.Maintain the delivery tube position within the detacher and use a thumb to pull back the slider on the detacher.Continue to pull on the slider until end of travel or a click is heard.Gently release the slider until it returns to starting position or a second click is heard.Remove detacher by slowly withdrawing it from the delivery tube.It further states that if 2 unsuccessful detachments occur, discard the detacher and proceed to manual break.Although the detacher mechanism could not be actuated and required the use of manual break and/or additional coil manipulation the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote thus the event does not meet usfda mdr reporting criteria under 21 cfr 803 and will be processed accordingly.The file will be re-reviewed if additional information is received at a later date.

• Brand Name: MECHANICAL DETACHMENT HANDLE
• Type of Device: CEREPAK DETACHABLE COIL SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS, INC.; calle circuito int norte 1820; parque industrial salvacar; juarez 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17107740
• MDR Text Key: 317025369
• Report Number: 3008114965-2023-00371
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704084600
• UDI-Public: 10886704084600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDH1
• Device Catalogue Number: MDH1
• Device Lot Number: 101456956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: KELLY FORCEPS; UNIFORM 7MM X 30 CM
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female