MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL10 1.5MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF100154
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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)).The device is available to be returned for evaluation and testing.However, it has not been received to date.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization, the physician didn't like the shape of a 1.5mm x 4cm deltafill coil (dlf100154, l11298) deployment and decided to pull it out.During resheathing of the coil, the introducer failed to be re-zipped.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.The complaint product was the second coil to be used.
Additional Manufacturer Narrative
Product complaint#: (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, the physician didn't like the shape of a 1.5mm x 4cm deltafill coil (dlf100154, l11298) deployment and decided to pull it out.During resheathing of the coil, the introducer failed to be re-zipped.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.The complaint product was the second coil to be used.One non-sterile unit deltafill10 1.5mm x 4cm 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 in good conditions.The introducer was inspected and it was found partially unzipped and kinked.The re-sheathing tool was inspected and it was found in good conditions.Also, the marker band was found at 39cm from hub, and it was found within specification.The v-notch was inspected under microscope and no damages were noted on it.The rh was inspected under microscope and it was found in good conditions.The embolic coil was inspected under microscope and no damages was noted on it.A manufacturing record evaluation was performed for the finished device l11298 number, and no non-conformances related to the reported complaint condition were identified the complaint reported by the customer ¿coil introducer - zipping difficulty-rezipping¿ was not able to evaluate due the conditions of the received device (introducer partially unzipped and kinked).The complaint reported by the customer ¿coil introducer - positioning difficulty-poor conformability¿ could not be evaluated because it is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab.The kinked condition appears 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 nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.Multiple attempts to obtain additional information were unsuccessful.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the ability to perform functional testing due to the conditions of the device received ; 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 with the coil failing to detach.The instructions for use (ifu) instructs on proper positioning of the microcoil system.The ifu also warns: ¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system¿.The 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.

• Brand Name: DELTAFILL10 1.5MM X 4CM
• 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: 8907049
• Report Number: 3008114965-2019-01147
• Device Sequence Number: 14135930
• Product Code: KRD
• UDI-Device Identifier: 10886704076957
• UDI-Public: 10886704076957
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2019

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: 12/31/2020
• Device Catalogue Number: DLF100154
• Device Lot Number: L11298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1