MAUDE Adverse Event Report: SEE H.10 DELTAPL CERE COIL 10 SYS 1.5X1; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CPL10015130
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physical manufacturer name: (b)(4) inc., dba depuy synthes products, inc.((b)(6)).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.This is one of 3 products involved with the reported complaint and the associated manufacturer report numbers are 3008114965-2018-00694, and 3008114965-2018-00695.
Event or Problem Description
The healthcare professional reported that during the procedure when the physician attempted to detach the deltaplush 10 cerecyte coil 1.5mm x 1cm (cpl10015130 / lot# unavailable), the detachment control made the normal beeping sound but when the physician was retrieving the delivery system, the coil failed to detach.The physician used another deltaplush coil and the procedure was successfully completed.There was no report of patient injury or adverse event.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during the procedure when the physician attempted to detach the deltaplush 10 cerecyte coil 1.5mm x 1cm (cpl10015130 / lot # unavailable), the detachment control made the normal beeping sound but when the physician was retrieving the delivery system, the coil failed to detach.The physician used another deltaplush coil and the procedure was successfully completed.There was no report of patient injury or adverse event.Multiple attempts were made to obtain additional information such as the intended procedure, target vessel, the lot number of the device, and other product and procedural-related information pertaining to this complaint.However, no further information has been made available.The device was received for analysis.The investigational finding is documented below.Investigation summary: the three products involved in the reported complaint were returned in the same package, unidentified.The device assigned to this product investigation file was returned with the coil introducer almost completely sheathed as indicated by its length proximal to the resheathing tool.The device was returned with the embolic coil inside the green introducer.The device positioning unit (dpu) core wire was kinked at approximately 32 cm from the proximal end of the device.Distal ball tip of embolic coil is present inside the green introducer.The embolic coil is observed to be kinked inside the green introducer.The articulating joint is present inside the green introducer.The v-notch of the resheathing tool was returned undamaged.The embolic coil was advanced from the green introducer.The embolic coil distal ball tip observed to be deformed.The proximal end of the embolic coil was observed to be stretched.The articulating joint observed to be intact.The distal outer sheath was observed to be straight, indicating that the detachment process was not initiated.Kinks were observed in the embolic coil.The resistance of the device was measured by to be 51.2 ohms, which is within the specification range of 48.5 ¿ 56.0.The device was attached to the lab sample enpower control cable (c10702) and enpower detachment control box (b)(4) (dcb) c38341.The dcb was powered on and the system ready light illuminated.The embolic coil was submerged in a heated enzyme solution and the detach button on the dcb was pressed resulting in a successful detachment of the embolic coil.The lot number of the device is unknown and is not available.Without the lot number, manufacturing information and device history record (dhr) review could not be reviewed.Investigation conclusion: the complaint of coil failure to detach is not confirmed.The device measured within specification for resistance and successfully performed embolic coil detachment with a lab-supplied dcb.The equipment (dcb and control cable) used in the operation was not returned and therefore the cause of the complaint failure cannot be determined.The ifu provides instructions for performing the detachment process for this device.The observed deformations of the coil, ball tip, and kinks in the dpu core wire are likely caused from applied excessive force.100% of embolic coils are inspected at the ball tip and along its length.It is unlikely that the device left the manufacturing facility with the observed damages.With the limited information available and without all the equipment used in the procedure returned for analyses, the extent of the investigation was limited and the reported issue that the deltaplush 10 cerecyte coil 1.5mm x 1cm failed to detach during the procedure could not be confirmed during functional testing of the returned device.The returned device was measured, and the resistance was determined to be within specification.The embolic coil successfully detached.The stretched condition of the coil and kinks observed on the coil and on the dpu core wire suggest that excessive force was applied.The device lot number was one of the additional information requested but was not available; as a result, the device history record and manufacturing record of this device could not be reviewed.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the deltaplush 10 cerecyte coil 1.5mm x 1cm left the manufacturing facility with the damages such as the stretched condition of the coil, the observed kinks on both the coil and the dpu.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.This is one of 3 products involved with the reported complaint and the associated manufacturer report numbers are 3008114965-2018-00694, and 3008114965-2018-00695.

• Brand Name: DELTAPL CERE COIL 10 SYS 1.5X1
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7752571
• Report Number: 3008114965-2018-00696
• Device Sequence Number: 1263379
• Product Code: HCG
• UDI-Device Identifier: 00878528008163
• UDI-Public: 00878528008163
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2018

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 Catalogue Number: CPL10015130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: 07/15/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1