MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAPL CERE COIL 10 SYS 1.5X3; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CPL10015330
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Based on the product analysis completed on 11-jan-2019, the event now meets the required criteria for mdr reporting as a "malfunction".Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The product lot number was not reported.Complaint conclusion: as reported by a healthcare professional, the physician did not like the shape of coil deployment of the 1.5mm x 2cm deltapaq (cdf10015230/unk lot), 1.5mm x 3cm deltaplush 10 (cpl10015330/unk lot), and the 5mm x 9.7cm micrusphere 10 (csp10050030/unk lot) and decided to remove the coils from the patient; however, while resheathing the coils, the introducers failed to be rezipped.The coil was replaced with a same-like coil, and the procedure was completed successfully.There was no report of consequence or impact to the patient.Multiple attempts were made without success to obtain additional information.The 1.5mm x 3cm deltaplush 10 was returned for evaluation.The device was returned with the embolic coil detached.The emboli ccoil was not returned for analysis.Kinks were observed on the device positioning unit (dpu) core wire approximately 30 cm, 73 cm, and 91 cm from the proximal end of the device.The device was returned partially unzipped with the dpu core wire exiting the resheathing tool outside of the introducer sheath.The dpu core wire remained outside the introducer until the end of the translucent part of the introducer where it was seen protruding from the skive within 2 cm from the green introducer.The device was then inspected under a microscope.The embolic coil was detached.The distal outer sheath had not softened, indicating that the resistance heating coil had not heated.Therefore, the detachment process operated by a detachment control box had not been initiated.The embolic coil was detached mechanically.The v-notch of the resheathing tool was seen damaged with a fracture down its center.The introducer had been kinked proximal to the resheathing tool.The skive had been widened at this location.The sterile lot number was not reported; therefore, a review of the manufacturing documentation could not be performed.The customer report of positioning difficulty could not be evaluated since positioning difficulty is specific to both procedure and situation and cannot be reproduced or tested in the failure analysis lab.However, the observed damage to the dpu core wire may make it more difficult to achieve correct positioning.Kinks in the dpu core wire are indicative of the application of excessive force, often during advancement.100% of devices are inspected for kinks in the dpu assembly at final quality control (qc) inspection.Thus, it is unlikely that the device left the manufacturing facility with the observed kinks in the dpu core wire.The customer report of rezipping difficulty was confirmed.The device could not zip without the core wire protruding from the introducer skive.The v-notch of the resheathing tool was seen with a fracture and the introducer was seen kinked, indicating that the device was not properly unsheathed with the introducer being pulled away from the resheathing tool at a 45-degree angle, according to the instructions for use (ifu).The ifu also instructs the user to leave approximately 1 inch (2-3 cm) of the translucent introducer sheath visible on the distal end of the resheathing tool.Advancing the resheathing tool further than this will put strain on the distal end of the skive.This may cause the skive to remain open when attempting to resheathe the device and not re-form around the dpu.As a result, the dpu will not properly resheathe.Zipping functionality is verified in-process on all devices.Thus, it is unlikely that the device left the manufacturing facility with the reported failure.In addition, the embolic coil was not returned, and the device was seen with the indications that the coil was mechanically detached.While the sequence of events leading to the observed damage to the coil cannot be determined based on the condition of the returned device, coil damage/premature detachment typically occurs when an excessive retraction force is applied in the presence of resistance.100% of devices are inspected in-process for damage.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.The device does not present any obvious indication of manufacturing defect or anomaly that could have contributed to the event as reported.Rezipping difficulty and positioning difficulty are known potential issues associated with the use of the device.The instructions for use (ifu) contains several cautions relating to these situations, including instructions for troubleshooting the situations should they be encountered during use.Assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural/handling factors, including vessel/aneurysm characteristics, device manipulation, and device interaction, may have contributed to the reported failure and damages noted to the returned system.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-00876 & 3008114965-2019-00877.
Event or Problem Description
As reported by a healthcare professional, the physician did not like the shape of coil deployment of the 1.5mm x 2cm deltapaq (cdf10015230/unk lot), 1.5mm x 3cm deltaplush 10 (cpl10015330/unk lot), and the 5mm x 9.7cm micrusphere 10 (csp10050030/unk lot) and decided to remove the coils from the patient; however, while resheathing the coils, the introducers failed to be rezipped.The coil was replaced with a same-like coil, and the procedure was completed successfully.There was no report of consequence or impact to the patient.Evaluation of the returned deltaplush revealed premature detachment of the embolic coil.Multiple attempts were made without success to obtain additional information.

• Brand Name: DELTAPL CERE COIL 10 SYS 1.5X3
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8246075
• Report Number: 3008114965-2019-00876
• Device Sequence Number: 2141820
• Product Code: HCG
• UDI-Device Identifier: 00878528008194
• UDI-Public: 00878528008194
• 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
• Report Date (Section B): 10/16/2018

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: CPL10015330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1