MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 5MM X 20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180520
Medical Device Problem Codes	Material Rupture (1546); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, age, gender, 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 during the procedure, the 7mm x 21cm galaxy g3 coil (gly120721 / l15620) and the 5mm x 20cm deltafill 18 coil (dlf180520 / l16341) were inserted into a concomitant prowler select plus microcatheter (catalog and lot number unknown) but there was a slight resistance felt.The physician kept pushing them but they were not able to advance.It was reported that the physician checked his hand, he noticed that the sheaths on the coils were torn and the delivery wires were protruding from the sheaths.The physician attempted to retract the coils but the coil components became damaged and were no longer able to be used.It was reported that the coil components may have gotten stuck on the peel away parts and became stretched.The coils were replaced ad the procedure resumed to completion.The complaint products are reported as not available to be returned for evaluation and analyses.There was no report of any patient adverse event or complication.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (l16341) 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 evaluation and analysis cannot be conducted as the product was not available to be returned.Determination of causes and possible contributing factors could not be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.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 issue.Based on the manufacturing documentation 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00377.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 procedure, the 7mm x 21cm galaxy g3 coil (gly120721 / l15620) and the 5mm x 20cm deltafill 18 coil (dlf180520 / l16341) were inserted into a concomitant prowler select plus microcatheter (catalog and lot number unknown) but there was a slight resistance felt.The physician kept pushing them but they were not able to advance.It was reported that the physician checked his hand, he noticed that the sheaths on the coils were torn and the delivery wires were protruding from the sheaths.The physician attempted to retract the coils but the coil components became damaged and were no longer able to be used.It was reported that the coil components may have gotten stuck on the peel away parts and became stretched.The coils were replaced ad the procedure resumed to completion.The complaint products are reported as not available to be returned for evaluation and analyses.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
(b)(4).The purpose of this mdr is to include the additional event information received on 09 september 2021.[additional information]: the healthcare professional reported that during the procedure, the 7mm x 21cm galaxy g3 coil (gly120721 / l15620) and the 5mm x 20cm deltafill 18 coil (dlf180520 / l16341) were inserted into a concomitant prowler select plus microcatheter (catalog and lot number unknown) but there was a slight resistance felt.The physician kept pushing them but they were not able to advance.It was reported that the physician checked his hand, he noticed that the sheaths on the coils were torn and the delivery wires were protruding from the sheaths.The physician attempted to retract the coils but the coil components became damaged and were no longer able to be used.It was reported that the coil components may have gotten stuck on the peel away parts and became stretched.The coils were replaced ad the procedure resumed to completion.The complaint products are reported as not available to be returned for evaluation and analyses.There was no report of any patient adverse event or complication.On 09 september 2021, additional information was received.The information indicated that the procedure was targeting an aneurysm on the superior mesenteric artery.There was nothing noted to be obstructing the microcatheter.There were no kinks on the microcatheter that may have contributed to the reported event.A continuous flush had been maintained through the microcatheter.The same microcatheter was used with both coils and it was not necessary to remove the microcatheter with the coil.There was no blood flow restriction / reduction as a result of the reported event.There was no clinically significant delay in the procedure due to the reported event.(b)(6).This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00377 and 3008114965-2021-00378.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 5MM X 20CM
• 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: 12380467
• Report Number: 3008114965-2021-00378
• Device Sequence Number: 4116255
• Product Code: KRD
• UDI-Device Identifier: 10886704076926
• UDI-Public: 10886704076926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/10/2021

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: 06/30/2022
• Device Model Number: DLF180520
• Device Catalogue Number: DLF180520
• Device Lot Number: L16341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/10/2021
• 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: GALAXY G3 7MM X 21CM; MICROCATHETER