MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 4MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF180415
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
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: 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).[conclusion]: the healthcare professional reported that during the isolation technique coil embolization procedure targeting a lesion at the lower pancreaticoduodenal artery, the excelsior® 1018® microcatheter (stryker) approached the target lesion and the 4mm x 15cm deltafill 18 coil (dlf180415 / l15213) was introduced but the coil could not be anchored.The physician attempted to resheath the coil for later use, but the introducer sheath became damaged and the coil could not be resheathed.It was reported that excessive force was not applied during the resheathing attempt.The coil was replaced, and the procedure was completed.There was no report of any patient injury or complication.It was reported that the devices are not available for return.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l15213) 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.Positioning difficulty / poor conformability is a known potential issue associated with the use of the device.Factors such as the shape of the target lesion, tortuosity of the parent vessel may have contributed to the way the coil is positioned and/or conforms when it gets delivered to the target site.With the limited information available 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.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that in this case, the aneurysm size / shape, and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported positioning difficulty / poor coil conformability.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.
Event or Problem Description
The healthcare professional reported that during the isolation technique coil embolization procedure targeting a lesion at the lower pancreaticoduodenal artery, the excelsior® 1018® microcatheter (stryker) approached the target lesion and the 4mm x 15cm deltafill 18 coil (dlf180415 / l15213) was introduced but the coil could not be anchored.The physician attempted to resheath the coil for later use, but the introducer sheath became damaged and the coil could not be resheathed.It was reported that excessive force was not applied during the resheathing attempt.The coil was replaced, and the procedure was completed.There was no report of any patient injury or complication.It was reported that the devices are not available for return.

• Brand Name: DELTAFILL18 4MM X 15CM
• 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: 8769716
• Report Number: 3008114965-2019-01065
• Device Sequence Number: 11273522
• Product Code: KRD
• UDI-Device Identifier: 10886704077206
• UDI-Public: 10886704077206
• 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
• Report Date (Section B): 06/17/2019

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: 02/28/2022
• Device Catalogue Number: DLF180415
• Device Lot Number: L15213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1