MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 3MM X 12CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF180312
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.The company is seeking this information through the event investigation.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, of a hemorrhage, a 3mm x 12cm deltafill18 coil (dlf180312, l14781) was used as the sixth coil.An electrical check was performed with the complaint cable, coil and microcatheter but the coil was not able to be detached.The detachment button was pressed several times.The coil was attempted to be re-sheathed but a guidewire was not able to be pulled out.The physician removed it with the microcatheter.The blood flow had almost stopped with the fifth coil and the procedure was completed.
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, of a hemorrhage, a 3mm x 12cm deltafill18 coil (dlf180312, l14781) was used as the sixth coil.An electrical check was performed with the complaint cable, coil and microcatheter but the coil was not able to be detached.The detachment button was pressed several times.The coil was attempted to be re-sheathed but a guidewire was not able to be pulled out.The physician removed it with the 150/5cm prowler select microcatheter.The blood flow had almost stopped with the fifth coil and the procedure was completed.Additional information received indicated that the failure occurred during use in the patient.The coil was removed from the patient without additional intervention.A non-sterile deltafill18 3mm x 12cm (pi-15714389406259934) was received inside of a pouch.The deltafill18 3mm x 12cm was partially inspected since part of the device was stuck inside the prowler sel plus 150/5cm 45tip received.The hub was inspected, and no damages were noted on it.The dpu was inspected and it was found stuck inside prowler sel plus 150/5cm 45tip at 33 cm.However, the rest of the device cannot be possibly analyzed since it was stuck inside the prowler sel plus 150/5cm 45tip.Also, the marker band could not be measured due the stuck condition from the device.The introducer was inspected, and it was found kinked.The re-sheating tool was found in good normal conditions.The v-notch was inspected under microscope and it was found in normal good condition.The rh and the articulation joint could not be evaluated since the device was stuck inside the prowler sel plus 150/5cm 45tip.The device was inspected under x-ray in order to verify if the coil had any damage or stretch condition, during this inspection it was noted that the embolic coil was detached from the device.The functional test could not be performed due the conditions of the device.A manufacturing record evaluation was performed for the finished device l14781 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - failure to detach¿ could not be evaluated since during the x-ray inspection it was noted that the embolic coil was not returned for evaluation.However, since the device is stuck in the prowler sel plus 150/5cm 45tip, cannot determine the cause for the detachment nor the exact time when this occur.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.Assignment of root cause for the event remains speculative and inconclusive, based on the provided.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.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.
Additional Manufacturer Narrative
(b)(4).Section b5: additional information received indicated that the failure occurred during use in the patient.The coil was removed from the patient without additional intervention.Section e1: initial reporter phone - (b)(6).Section h3: the product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

• Brand Name: DELTAFILL18 3MM X 12CM
• 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: 9250406
• Report Number: 3008114965-2019-01220
• Device Sequence Number: 2362611
• Product Code: KRD
• UDI-Device Identifier: 10886704077190
• UDI-Public: 10886704077190
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2019

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: 12/31/2021
• Device Catalogue Number: DLF180312
• Device Lot Number: L14781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/05/2019; 11/14/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 11/19/2019; 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENPOWER CONTROL CABLE; PROWLER SEL PLUS 150/5CM 45TIP