MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 6MM X 25CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180625
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Procode: krd/hcg.The name, phone 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 device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ as the reason for non-evaluation.If the device returns, a device investigation will be performed.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 pre-endovascular aneurysm repair (evar) embolization at the internal iliac artery, the 6mm x 25cm deltafill 18 coil (dlf180625 / l14373) was used as a filling coil, but there was a resistance felt between the hub of the microcatheter and the coil.This occurred when the coil was delivered to the target lesion.The complaint coil was re-sheathed, but it became unraveled.Another 6mm x 25cm deltafill 18 coil was used and the procedure was completed with 11 spectra coils.There was no report of any patient adverse event or complication associated with the reported issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 1/14/2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: d.10, g.4, g.7, h.2, h.3, h.6, and h.10.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (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 pre-endovascular aneurysm repair (evar) embolization at the internal iliac artery, the 6mm x 25cm deltafill 18 coil (dlf180625 / l14373) was used as a filling coil, but there was a resistance felt between the hub of the microcatheter and the coil.This occurred when the coil was delivered to the target lesion.The complaint coil was re-sheathed, but it became unraveled.Another 6mm x 25cm deltafill 18 coil was used and the procedure was completed with 11 spectra coils.There was no report of any patient adverse event or complication associated with the reported issue.The product was returned and received for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 6mm x 25cm deltafill 18 coil was returned and received contained in a pouch.The returned device underwent visual inspection.The introducer was observed separated from the unit.A microscopic inspection was performed.The marker band was found at 60 cm from the distal end; this is within specification.The embolic coil was observed separated from the device and in stretched condition.The distal outer sheath had not been softened, indicating that the resistance heating (rh) coil had not been heated and the detachment process has not been initiated.No other damages were observed.A review of manufacturing documentation associated with this lot (l14373) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue related to the resistance between the hub of the microcatheter and the coil could not be confirmed through functional testing due to the condition of the returned device.The coil introducer was received separated from the device.The condition of the embolic coil may have contributed to the reported issue, and based on the condition of the embolic coil, the customer complaint was confirmed.The coil may have become stretched through force that was inadvertently applied.Coil stretching / unraveling is a known potential issue associated with the use of this device.The instruction for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.The embolic coil can become unraveled or stretched during attempts to withdrawal it against resistance.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 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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 1/21/2020.E.1: the initial reporter phone: (b)(6).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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to report additional information and to make correction on the additional information that was received on 1/21/2020.The additional information and the corrected information was received from the affiliate on 1/23/2020.[additional information]: the healthcare professional reported that during the pre-endovascular aneurysm repair (evar) embolization at the internal iliac artery, the 6mm x 25cm deltafill 18 coil (dlf180625 / l14373) was used as a filling coil, but there was a resistance felt between the hub of the microcatheter and the coil.It was reported that a continuous flush had been maintained through the microcatheter.This occurred when the coil was delivered to the target lesion.The complaint coil was re-sheathed, but it became unraveled.Additional event information was received stated that the complaint coil became unraveled after it was pulled out and deliberately inserted into the microcatheter several times.Another 6mm x 25cm deltafill 18 coil was used and the procedure was completed with 11 spectra coils.There was no report of any patient adverse event or complication associated with the reported issue.E.1: the initial reporter phone: (b)(6).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 6MM X 25CM
• 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: 9511361
• Report Number: 3008114965-2019-01257
• Device Sequence Number: 2650934
• Product Code: KRD
• UDI-Device Identifier: 10886704076933
• UDI-Public: 10886704076933
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/02/2019

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: 10/31/2021
• Device Model Number: DLF180625
• Device Catalogue Number: DLF180625
• Device Lot Number: L14373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/14/2020; 01/16/2020; 01/21/2020; 01/23/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/14/2020; 01/16/2020; 01/21/2020; 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1