MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAPAQ CERE 5MMX15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10051530

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Based on the product analysis completed on (b)(6) 2018, this product event now meets the criteria for medical device reporting (mdr).Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Date of event: the event occurred in 2017; however, the month and day were not reported.Procode: krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)) the product lot number was not reported.Medical devices: 3mm x 6cm deltapaq detachable coil system (dcs) (cdf10030630/unk lot), 3mm x 8cm deltapaq detachable coil system (dcs) (cdf10030830/unk lot) complaint conclusion: as reported by a healthcare professional, a total of three thermo-mechanical coils, one 3mm x 6cm deltapaq (cdf10030630/unk lot), one 3mm x 8cm deltapaq (cdf10030830/unk lot), and one 5mm x 15cm deltapaq (cdf10051530/unk lot), failed to re-sheath during the procedure.The coils were replaced and the procedure was completed successfully.There was no report of consequence or impact to the patient.No further information was provided.Three devices were returned for this complaint.One of the devices has the embolic coil detached, and the other two are approximately the same length (approximately 15 cm).The devices documented in the complaint are 6 cm long, 8 cm long, and 15 cm long.Since 2 devices are approximately the correct length for cdf10051530/unk lot, none of the devices are demonstrably the correct length for cdf10030630/unk lot or cdf10030830/unk lot, and one of the devices has no attached embolic coil to measure, none of the devices could be clearly associated with any one of the impacted products in the complaint record.Multiple attempts to obtain clarification regarding the returned devices were unsuccessful.Since no further information could be obtained relating any returned item to any of the complaint devices, they were identified as device a, device b, and device c and arbitrarily assigned to the complaint devices for evaluation and conclusion purposes.The 3 devices were evaluated together.All 3 devices were evaluated with respect to the code ¿zipping difficulty-rezipping¿, which was assigned to all 3 products in the complaint.Device a (cdf10051530/unk lot): the embolic coil was not attached and was not returned.The distal end of the device positioning unit (dpu) was located in the green introducer, near its distal end.The device was almost fully sheathed.There were bends in the dpu core wire approximately 29 cm, 33 cm, 35 cm, and 92 cm from the proximal end.The embolic coil was not returned, so its dimensions could not be determined.The condition of the resistance heating (rh) coil was obscured by the green introducer.The v-notch of the resheathing tool was undamaged.The device was advanced out of the introducer to visualize the rh coil.The rh coil had not heated.There was blood on the rh coil.The device was partially unsheathed and an attempt was made to re-sheath the device.The device resheathed successfully.The lot number of the device is unknown.Without the lot number, manufacturing information cannot be reviewed.The complaint of rezipping difficulty was not confirmed.The device was returned almost fully zipped with no protrusions, and was successfully partially unzipped then rezipped.In addition, the embolic coil was not attached to the dpu and was not returned with the device.Microscopic evaluation of the rh coil indicated that the embolic coil detached mechanically.The exact circumstances surrounding the event are unknown and the detachment of the embolic coil is not documented in the complaint, which suggests that the detachment occurred following the reported event.Bends in the dpu core wire are indicative of the application of excessive force to the device.A bend in the dpu core wire can result in rezipping difficulty, if the bend must pass through the resheathing tool and be resheathed.The translucent introducer sheath cannot re-form around a bend in the dpu core wire, which would cause the core wire to protrude from the skive in the translucent introducer sheath.However, all of the observed bends in the dpu core wire were proximal to the resheathing tool, even with the dpu advanced almost to the end of the green introducer.Finally, no protrusions of the dpu or embolic coil were observed in the returned device, making the returned device inconsistent with the reported issue.The exact circumstances surrounding the condition of the returned device could not be determined.With review of the device 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, based on the analysis it appears that procedural and handling factors may have contributed to the reported failure to re-sheath 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 3008114965-2018-00605 & 3008114965-2018-00606.

Event Description

As reported by a healthcare professional, a total of three thermo-mechanical coils, one 3mm x 6cm deltapaq (cdf10030630/unk lot), one 3mm x 8cm deltapaq (cdf10030830/unk lot), and one 5mm x 15cm deltapaq (cdf10051530/unk lot), failed to re-sheath during the procedure.The coils were replaced and the procedure was completed successfully.There was no report of consequence or impact to the patient.No further information was provided.

• Brand Name: DELTAPAQ CERE 5MMX15CM
• 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: 7468205
• MDR Text Key: 107075097
• Report Number: 3008114965-2018-00606
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007302
• UDI-Public: 00878528007302
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K080437
• 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: 01/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDF10051530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2018
• 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