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

Catalog Number	DLF180625
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
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 is krd/hcg.Initial reporter information such as the name, phone and email address are not available.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).A review of manufacturing documentation associated with this lot (l11591) 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.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.The company is seeking this information through the event investigation.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 major aorto-pulmonary collateral artery (mapca) coil embolization procedure targeting the lesion at the collateral circulation coming from the right internal mammary artery, when the 6mm x 25cm deltafill 18 coil (dlf180625 / l11591) was approaching the target lesion, resistance was felt, and the physician pushed and withdrawn the coil.Then it was confirmed that the coil became unraveled.The coil was then removed from the patient¿s body together with the concomitant lighthouse® microcatheter (piolax medical).The prowler select plus lpes microcatheter was used and the procedure was completed.The physician commented that the tortuosity of the patient¿s vessels was severe.There was no report of patient injury or complication.All the devices were handled in accordance with the instructions for use (ifu).The complaint device was discarded due to infectious diseases.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on (b)(6) 2019.[conclusion]: the healthcare professional reported that during the major aorto-pulmonary collateral artery (mapca) coil embolization procedure targeting the lesion at the collateral circulation coming from the right internal mammary artery, when the 6mm x 25cm deltafill 18 coil (dlf180625 / l11591) was approaching the target lesion, resistance was felt, and the physician pushed and withdrawn the coil with the concomitant lighthouse® microcatheter (piolax medical); then it was confirmed that the coil became unraveled.It was reported that a continuous flush had not been maintained through the microcatheter, but prior to this coil, there were other coils that were able to go through the microcatheter without any resistance.The prowler select plus lpes microcatheter was used and the procedure was completed with a new coil.The physician commented that the tortuosity of the patient¿s vessels was severe.There was no report of patient injury or complication, no procedural delay and no additional intervention required.All the devices were handled in accordance with the instructions for use (ifu).The complaint device was discarded due to infectious diseases.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l11591) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information provided and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.Additional information reported that a continuous flush had not been maintained through the microcatheter, the instruction for use (ifu) states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.The reported event was related to resistance, then the coil became unraveled when it was withdrawn with the microcatheter.The insufficient flush likely contributed to the resistance issue reported and resulted in the coil becoming unraveled.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.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: 8588472
• Report Number: 3008114965-2019-01001
• Device Sequence Number: 13886083
• 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
• Report Date (Section B): 04/17/2019

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: 01/31/2021
• Device Catalogue Number: DLF180625
• Device Lot Number: L11591
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1