MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 6X15; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0615
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was noted to being stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00302 and 3008114965-2020-00303.Complaint conclusion: as reported by the field, during a coil embolization, re-sheating failed with a 1.5mm x 3cm deltaxsft10 (dlx100153, l15277 ) and a 6x15 og tdl cmplx fill coil (640cf0615,17710987).The procedure was successfully finished.There was no patient injury reported.Based on the findings of the device investigation, the embolic coil was noted to being stretched and kinked on the deltaxsft10.The embolic coil was found stretched on the og tdl cmplx fill coil.One non-sterile og tdl cmplx fill coil 6x15 was received inside of a pouch.The received device was visually inspected, and the hypo-tube was found kinked at 147.8cm from the proximal end.The introducer was found in good condition, but it was found partially zipped.Then a microscopic inspection was performed, the embolic coil was found stretched outside from the introducer.No other damages could be observed.A manufacturing record evaluation was performed for the finished device 17710987 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil introducer - zipping difficulty-rezipping¿ the introducer could not be zipped due the conditions of the device (hyportube kinked, coil stretched) and because of this we can confirm the complaint.The kinked and stretched condition noted on the device may have appeared to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis or the mre suggest that the failure reported could be related to the manufacturing process.The instructions for use (ifu) instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the embolic coil or the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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.
Event or Problem Description
As reported by the field, during a coil embolization, re-sheating failed with a 1.5mm x 3cm deltaxsft10 (dlx100153, l15277 ) and a 6x15 og tdl cmplx fill coil (640cf0615, 17710987).The procedure was successfully finished.There was no patient injury reported.Based on the findings of the device investigation, the embolic coil was noted to being stretched and kinked on the deltaxsft10.The embolic coil was found stretched on the og tdl cmplx fill coil.

• Brand Name: OG TDL CMPLX FILL COIL 6X15
• 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: 10333057
• Report Number: 3008114965-2020-00303
• Device Sequence Number: 19635671
• Product Code: KRD
• UDI-Device Identifier: 10886704030331
• UDI-Public: 10886704030331
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2020

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: 06/30/2019
• Device Model Number: 640CF0615
• Device Catalogue Number: 640CF0615
• Device Lot Number: 17710987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1