MAUDE Adverse Event Report: SEE H.10 DELTAFILL18 8MM X 35CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF180835
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).Concomitant med products: sheath introducer (medikit), guidewire (chikai 14, asahi intecc), guiding catheter (fubuki, asahi intecc), microcatheter (echelon 10, covidien, (b)(4)).[conclusion]: the healthcare professional reported that during the coil embolization procedure to treat a subarachnoid hemorrhage of a 9mm aneurysm at the internal carotid c3 segment, a guiding catheter and the microcatheter were inserted from the right femoral artery and advanced to the lesion.The deltafill 18 8mm x 35cm coil (dlf180835 / s12417) was inserted and it was found that the coil did not fit the lesion; the deltafill coil was removed and it became unraveled in the microcatheter.It was replaced with another coil and the procedure was successfully completed without further issues or delay.There was no report of patient injury or complication; the product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.The deltafill coil was reported as not available to be returned for investigation.No further information was available.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (s12417) 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.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of causes and possible contributing factors could be made.As such the investigation will be closed.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.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure to treat a subarachnoid hemorrhage of a 9mm aneurysm at the internal carotid c3 segment, a guiding catheter and the microcatheter were inserted from the right femoral artery and advanced to the lesion.The deltafill 18 8mm x 35cm coil (dlf180835 / s12417) was inserted and it was found that the coil did not fit the lesion; the deltafill coil was removed and it became unraveled in the microcatheter.It was replaced with another coil and the procedure was successfully completed without further issues or delay.There was no report of patient injury or complication; the product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.The deltafill coil was reported as not available to be returned for investigation.No further information was available.

• Brand Name: DELTAFILL18 8MM X 35CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7712932
• Report Number: 3008114965-2018-00667
• Device Sequence Number: 14146172
• Product Code: KRD
• UDI-Device Identifier: 10886704077220
• UDI-Public: 10886704077220
• 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): 07/04/2018

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: 09/30/2019
• Device Catalogue Number: DLF180835
• Device Lot Number: S12417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1