MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX CERECYTE 18SYS 8X35; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDX18083530
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
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.Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(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 a healthcare professional, during a coil embolization, a 8x35 deltamaxx cerecyte 18sys (cdx18083530, s13453) was being used for filling, however, the physician didn't like the shape of the coil deployment and decided to pull it out.During resheathing the coil, the introducer was defected not to be unzipped.The physician used a same like product and the procedure was successfully finished.There was no patient injury reported.Multiple attempts to obtain additional information were unsuccessful.One non-sterile deltamaxx cerecyte 18sys 8x35 was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and it was found kinked at 6cm from the proximal end.The introducer was inspected, and it was found partially zipped and it was found kinked.The re-sheating tool was inspected and it was found broken in two.The v-notch was inspected under microscope and it was found in good conditions.The rh was inspected under microscope and its was found no heated and with no damages on it, outside of the introducer.The embolic coil was inspected under microscope and its was found stretched and several tangled with the device.The functional test could not be performed due the conditions of the received device (several tangles).A manufacturing record evaluation was performed for the finished device s13453 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil introducer - zipping difficulty-unzipping¿ was not able to confirm due the re-sheating tool was found broken in two.The complaint reported by the customer ¿coil introducer - damage¿ was confirmed due on the visual analysis the introducer was found kinked.The stretched condition appears to have been caused by excessive force and handling being applied to the device and may have contributed to the failures reported, however none of those can be conclusively determined.Neither the device history record review nor the product analysis suggest that the reported failures could be related to the manufacturing process of the unit.Based on the limited information available for review, it is possible that procedural and handling factors may have contributed to the reported events.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.The instructions for sue (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.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.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization, a 8x35 deltamaxx cerecyte 18sys (cdx18083530, s13453) was being used for filling, however, the physician didn't like the shape of the coil deployment and decided to pull it out.During resheathing the coil, the introducer was defected not to be unzipped.The physician used a same like product and the procedure was successfully finished.There was no patient injury reported.Multiple attempts to obtain additional information were unsuccessful.Based on the analysis of the device received, the embolic coil was found stretched.

• Brand Name: DELTAMAXX CERECYTE 18SYS 8X35
• 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: 8893077
• Report Number: 3008114965-2019-01139
• Device Sequence Number: 18911638
• Product Code: KRD
• UDI-Device Identifier: 10878528008597
• UDI-Public: 10878528008597
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K120274
• 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): 03/29/2019

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: 02/28/2022
• Device Catalogue Number: CDX18083530
• Device Lot Number: S13453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1