MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL10 7MMX20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF100720
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient's date of birth, weight, race, and ethnicity were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that the (b)(6) male patient presented with a right lateral wide neck basilar aneurysm with subarachnoid hemorrhage underwent the endovascular embolization procedure.A balloon catheter, microcatheter and a 7f catheter were used with the 7mm x 20cm deltafill 10 coil (dlf100720 / l14263).When they drained off the balloon catheter, the coil ¿started to fall out.¿ the physician wanted to remove the coil and it was the first attempt when the coil broke into two pieces.The physician was able to catch the smaller piece with the balloon catheter and the other piece together with the microcatheter.The reported event resulted in a 10-minute procedure delay.There was no adverse event or complication to the patient.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (l14263) 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.Microcoil migration and coil separation are known potential complications associated with coil embolization procedures.With the information available, but without the complaint product available for return, the cause of the reported issues cannot be determined.Based on the manufacturing documentation 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 sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported event documented in the complaint.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 the (b)(6) male patient presented with a right lateral wide neck basilar aneurysm with subarachnoid hemorrhage underwent the endovascular embolization procedure.A balloon catheter, microcatheter and a 7f catheter were used with the 7mm x 20cm deltafill 10 coil (dlf100720 / l14263).When they drained off the balloon catheter, the coil ¿started to fall out.¿ the physician wanted to remove the coil and it was the first attempt when the coil broke into two pieces.The physician was able to catch the smaller piece with the balloon catheter and the other piece together with the microcatheter.The reported event resulted in a 10-minute procedure delay.There was no adverse event or complication to the patient.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 08 february 2021.[additional information]: the healthcare professional reported that the 50-year-old male patient presented with a right lateral wide neck basilar aneurysm with subarachnoid hemorrhage underwent the endovascular embolization procedure.It was reported that the vessel tortuosity was normal.A balloon catheter, microcatheter and a 7f catheter were used with the 7mm x 20cm deltafill 10 coil ((b)(4) / l14263).There was no difficulty positioning the coil in the target site.When they drained off the balloon catheter, the coil ¿started to fall out.¿ the physician wanted to remove the coil and it was the first attempt when the coil broke into two pieces.The physician was able to catch the smaller piece with the balloon catheter and the other piece together with the microcatheter.The coil came out in two pieces, one long piece with the introducer, the other short piece with the balloon catheter.It was confirmed that there was no coil piece left in the patient.The coil pieces were discarded.The reported event did not result in reduced / restricted blood flow in the parent vessel, there was no evidence of thrombosis.The reported event resulted in a 10-minute procedure delay.The delay was not considered clinically significant.There was no adverse event or complication to the patient.The procedure was successfully completed with other type of coils without any neuro deficit to the patient.Updated sections: e.1, e.3, g.3, g.6, h.2, 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.

• Brand Name: DELTAFILL10 7MMX20CM
• 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: 11248351
• Report Number: 3008114965-2021-00010
• Device Sequence Number: 19745032
• Product Code: KRD
• UDI-Device Identifier: 10886704079408
• UDI-Public: 10886704079408
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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: DLF100720
• Device Catalogue Number: DLF100720
• Device Lot Number: L14263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 02/08/2021
• 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: 7F CATHETER (UNKNOWN BRAND).; BALLOON CATHETER (UNKNOWN BRAND).; MICROCATHETER (UNKNOWN BRAND).
• Patient Age: 50 YR