MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FRAME COIL 7X25; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CR0725
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization to an aneurysm to the anterior communicating artery, a 7x25 orbit galaxy coil (640cr0725, 30734738) became impeded in the tip of a prowler select plus 150/5cm microcatheter (606-s255x, 30743230) and could not advance or withdraw.The physician retracted the coil and microcatheter, then switched to a new coil (the microcatheter was not replaced) to complete the surgery.There was no patient injury reported.Additional information received indicated that there was no damage to the microcatheter during manipulation of the device or noticed to be damaged upon removal from the patient.There was no damage noted to the coil.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.
Additional Manufacturer Narrative
Product complaint (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.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 number is 3008114965-2022-00743.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).Complaint conclusion: as reported by the field, during a coil embolization to an aneurysm to the anterior communicating artery, a 7x25 orbit galaxy coil (640cr0725, 30734738) became impeded in the tip of a prowler select plus 150/5cm microcatheter (606-s255x, 30743230) and could not advance or withdraw.The physician retracted the coil and microcatheter, then switched to a new coil (the microcatheter was not replaced) to complete the surgery.There was no patient injury reported.Additional information received indicated that there was no damage to the microcatheter during manipulation of the device or noticed to be damaged upon removal from the patient.There was no damage noted to the coil.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.A non-sterile og tdl cmplx frame coil 7x25 was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and one (1) kink condition was found at 150 cm on the delivery wire, this measurement was taken from the proximal end of the device.The device was inspected under microscopic magnification, and the coil was noted to be in good condition (i.E., no elongations, kinks, or non-concentric loops were noted) inside the introducer.It is possible that force may have inadvertently been applied during the maneuvering of the coil, which resulted in the kinked condition found in the delivery wire resulting in the coil impeding in the microcatheter.The condition described above precluded proper testing.Even with this, the customer complaint was confirmed since the coil could not move.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: ¿ never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.¿if friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: OG TDL CMPLX FRAME COIL 7X25
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15771417
• Report Number: 3008114965-2022-00742
• Device Sequence Number: 6630454
• Product Code: KRD
• UDI-Device Identifier: 10886704030447
• UDI-Public: 10886704030447
• 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
• Report Date (Section B): 12/07/2022

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: 12/31/2023
• Device Model Number: 640CR0725
• Device Catalogue Number: 640CR0725
• Device Lot Number: 30734738
• 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: 10/27/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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 PLUS 150/5CM
• Patient Sex: Unknown