MAUDE Adverse Event Report: SEE H.10 DELTAPL CERE COIL 10 SYS 2X6; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CPL10020630
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).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.The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the procedure, the deltaplush 10 cerecyte coil 2mm x 6cm ((b)(4)) could not be detached.The coil was withdrawn and another coil was used to complete the procedure.There was no report of any patient injury or consequence.
Additional Manufacturer Narrative
(b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure of an intracranial aneurysm, the deltaplush 10 cerecyte coil 2mm x 6cm (b)(4) could not be detached.The coil was withdrawn and successfully removed from the patient still attached to the delivery system and not stretched.It was confirmed that the coil delivery system was prepped without any issue or difficulty.It was also confirmed that prior to the attempt to detach, it was verified under fluoro that there was no stress against the microcatheter or delivery tube.Another coil was used to complete the procedure.There was no report of any patient injury or consequence.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (c26421) 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.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.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.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.

• Brand Name: DELTAPL CERE COIL 10 SYS 2X6
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7712615
• Report Number: 3008114965-2018-00660
• Device Sequence Number: 1018203
• Product Code: HCG
• UDI-Device Identifier: 00878528008231
• UDI-Public: 00878528008231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083646
• 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,Followup
• Report Date (Section B): 07/02/2018

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: 04/30/2019
• Device Catalogue Number: CPL10020630
• Device Lot Number: C26421
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1