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

Catalog Number	DLF180312
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode: krd/hcg.Initial reporter phone: (b)(6).The name and email address of the initial reporter are not available / reported.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure for a subarachnoid hemorrhage (sah), after several spectra coils were used and implanted without any issue, the 3mm x 12cm deltafill 18 coil (dlf180312 / l14828) was used but the coil size did not fit.The physician was attempting to resheath the coil, but it became prematurely detached in the headway® microcatheter (microvention).The coil was removed from the patient¿s body with the concomitant microcatheter.The physician then made another attempt with the microcatheter to access the target lesion and again, several coils were used.The procedure was completed with the 4mm x 15cm deltafill 18 coil.There was no report of any patient injury or complication.The product was returned and is pending evaluation.
Additional Manufacturer Narrative
(b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the coil embolization procedure for a subarachnoid hemorrhage (sah), after several spectra coils were used and implanted without any issue, the 3mm x 12cm deltafill 18 coil (dlf180312 / l14828) was used but the coil size did not fit.The physician was attempting to resheath the coil, but it became prematurely detached in the headway® microcatheter (microvention).The coil was removed from the patient¿s body with the concomitant microcatheter.The physician then made another attempt with the microcatheter to access the target lesion and again, several coils were used.The procedure was completed with the 4mm x 15cm deltafill 18 coil.There was no report of any patient injury or complication.The product was returned for evaluation.The investigational finding is documented below.Investigation summary: the non-sterile 3mm x 12cm deltafill 18 coil was received contained in a pouch.Visual inspection was performed.The hub was inspected and observed without any appearance of damage.The device positioning unit (dpu) was observed kinked.The coil introducer and the resheathing tool were not received with the returned device.The marker band was found 47 cm from the distal end; this is within specification.Microscopic inspection was performed.The outer sheath of the resistance heating (rh) had not been softened, indicating that the resistance heating coil had not been heated and the detachment process had not been initiated.The embolic coil was not returned.A review of manufacturing documentation associated with this lot (l14828) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue documented in the complaint that the 3mm x 12cm deltafill 18 coil had become prematurely detached in the concomitant microcatheter during removal could not be confirmed through functional evaluation; it was confirmed through microscopic inspection performed on the returned device.Under microscopic inspection, the distal outer sheath of the resistance heating did not have the softened appearance, an indication that the resistance heating coil has not been heated and the coil detachment process has not been initiated.The embolic coil was not attached and was not returned; therefore, it can be confirmed that the coil did unintendedly detach, although the exact timing of the coil detachment cannot be determined.The exact cause of the premature coil detachment could not be conclusively determined, the resistance heating did not show evidence of being heated, which indicated that the detachment process was not initiated.The premature detachment occurred during the resheathing attempt inside the concomitant microcatheter when it was determined that the coil size did not fit the target lesion.It is possible that force was inadvertently exerted on the coil during the attempt to resheath, which resulted in the coil becoming prematurely detached inside the microcatheter.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event of failure to detach was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.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: 8809511
• Report Number: 3008114965-2019-01082
• Device Sequence Number: 321055
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: L14828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1