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

Catalog Number CPL10015330

Device Problems Kinked (1339); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Based on the product analysis completed on 3/21/2018, this product event has been deemed fda mdr reportable.Information regarding patient age, gender, weight, medical history, race, and ethnicity were not provided.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The product lot number was not reported.Concomitant med products: deltapaq 10 cerecyte coil 3mm x 6cm (cdf10030630/lot unk).Complaint conclusion: as reported by a healthcare professional, abnormal friction was encountered between the coil delivery wire and the coil introducer of a 3mm x 6cm deltapaq 10 cerecyte (cdf10030630/lot unknown) and a 1.5mm x 3cm deltaplush10 cerecyte (cpl10015330/lot unknown).It is not known how the procedure was completed or if there was any injury to the patient.No further information was provided.Two delta-shaped devices were returned for this complaint separately, but without labeling.The devices were different lengths.This device was identified as being approximately 3 cm long.The embolic coil was separated from the device positioning unit (dpu) and located in the green introducer.The distal end of the dpu was located in the green introducer, near its proximal end.The dpu core wire had protruded from the skive of the translucent introducer sheath.There were no apparent kinks or bends in the dpu core wire.The ball tip was intact.The embolic coil was kinked, folded over, and separated.The distal segment of embolic coil was located near the distal end of the green introducer.The proximal solder ring section of the embolic coil was attached to the dpu, and was located near the proximal end of the green introducer.The condition of the articulating joint and resistance heating (rh) coil was obscured by the green introducer.The protruded core wire passed into the resheathing tool.There was a very slight amount of plastic remodeling damage to the v-notch of the resheathing tool.The damage to the embolic coil prevented it from being advanced or retracted.The lot number of the device is unknown.Without the lot number, manufacturing information cannot be reviewed.The complaint of resistance or friction with the introducer was confirmed.The embolic coil was separated, and the proximal end of the distal segment was kinked and folded over in the green introducer.This damage had caused the segment of embolic coil to lodge in the introducer, and it could not be advanced.The ball tip and proximal solder ring were both present, indicating that the returned embolic coil was complete.The damage to the embolic coil is indicative of the application of excessive force, possibly in an attempt to overcome reported resistance.The cause of the reported resistance is not apparent from the condition of the returned device.While the exact circumstances of the event are unknown, it is possible that an outside factor, such as poor alignment between the introducer and the microcatheter hub, caused the initial resistance.Application of excessive force to the device then caused the observed damage to the embolic coil.Separation of the embolic coil is likely to have occurred as a result of application of excessive force in an attempt to retract the lodged embolic coil.Protrusion of the dpu core wire through the skive of the translucent introducer sheath is likely to have occurred as a result of the same application of excessive force that damaged the embolic coil.With review of the product analysis, there is no indication of any manufacturing issues related to the reported event or damages noted on the returned system.Although a definitive conclusion cannot be made, it appears that circumstances of the procedure may have contributed to the event and damages noted on the returned device.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.This is one of two products involved with the reported complaint and the associated manufacturer report numbers are 3008114965-2018-00583 & 3008114965-2018-00584.

Event Description

As reported by a healthcare professional, abnormal friction was encountered between the coil delivery wire and the coil introducer of a 3mm x 6cm deltapaq 10 cerecyte thermo-mechanical coil (cdf10030630/lot unknown) and a 1.5mm x 3cm deltaplush10 cerecyte thermo-mechanical coil (cpl10015330/lot unknown).It is not known how the procedure was completed or if there was any injury to the patient.No further information was provided.

• Brand Name: DELTAPL CERE COIL 10 SYS 1.5X3
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• Manufacturer (Section G): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; chemin-blanc 38; le locle neuchatel CH-24-00 ; SZ CH-2400 ; 949789-868
• MDR Report Key: 7372772
• MDR Text Key: 241265926
• Report Number: 3008114965-2018-00583
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008194
• UDI-Public: 00878528008194
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/25/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: CPL10015330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1