MAUDE Adverse Event Report: SEE H.10 DELTAXSFT10 2MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100206
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
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.(b)(4).Initial reporter information such as the name, phone and email address are unknown.[conclusion]: the healthcare professional reported that during the procedure, the deltaxsft 10 2mm x 6cm coil (dlx100206 / l10673) did not pass through the microcatheter.Limited information is available related to the details of the procedure.There was no report of any patient injury or adverse event.The deltaxsft 10 coil was returned for evaluation.The investigational finding is documented below.Investigation summary: the device was received with the embolic coil tangled around the device positioning unit (dpu) core wire.The original packaging label returned with the device matched the complaint information.The device was returned unsheathed as indicated by the length of the introducer proximal to the resheathing tool.The device was returned with the embolic coil advanced from the green introducer.No kinks were observed on the dpu core wire.The device was put under a microscope for analysis.The ball tip was seen present and intact.A small amount of blood was present on the embolic coil.The embolic coil was seen kinked in two locations.The embolic coil was stretched at its proximal end.The distal outer sheath had not softened indicating that the detachment process had not been initiated.The articulating joint was seen intact.The v-notch of the resheathing tool was seen to be slightly damaged- no fractures were present; however, the v-notch was dented.The skive of the introducer proximal to the resheathing tool was seen with a widened opening.The device could not be advanced through a microcatheter due to the condition in which it was returned.The stretched embolic coil prevented advancement of the device.A review of manufacturing documentation associated with this lot (l10673) 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.Investigation conclusion: the issue reported in the complaint of the coil not being able to pass through the microcatheter is confirmed.The device could not be advanced through a lab-provided microcatheter because the embolic coil was returned stretched and kinked.The damage to the resheathing tool and gap in the introducer proximal to the resheathing tool indicates that the device was not properly unlocked.The ifu instructs the user to unlock the device by gently pulling the clear tab of the introducer sheath out and away from the re-sheathing tool at a 45-degree angle.Pulling the tab straight out (in parallel to the dpu) will result in damage to the resheathing tool and may cause damage to the embolic coil.100% of embolic coils are inspected in-process for damage, kinks, and stretching.In addition, 100% of resheathing tools are inspected during zipping functionality testing before loading into the packaging hoop.It is unlikely that the device left the manufacturing facility with the observed damage.With limited information available related to this complaint, the complaint product was returned and underwent functional analysis.The reported issue that the deltaxsft 10 coil did not pass through the microcatheter was confirmed; the device could not be advanced through a lab sample microcatheter due to the kinked and stretched condition of the embolic coil.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.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the deltaxsft 10 2mm x 6cm coil left the manufacturing facility with the coil kinked and in a stretched condition as noted during the product evaluation.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.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 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 deltaxsft 10 2mm x 6cm coil (dlx100206 / l10673) did not pass through the microcatheter.Limited information is available related to the details of the procedure.There was no report of any patient injury or adverse event.The product is available to be returned for evaluation.

• Brand Name: DELTAXSFT10 2MM X 6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8010725
• Report Number: 3008114965-2018-00781
• Device Sequence Number: 13824043
• Product Code: KRD
• UDI-Device Identifier: 10886704077336
• UDI-Public: 10886704077336
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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: 10/31/2020
• Device Catalogue Number: DLX100206
• Device Lot Number: L10673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1