MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAPAQ CERE 1.5MMX2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDF10015230
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Based on the product analysis completed on 08-jan-2019, this event meets the required criteria for mdr reporting.Procode: krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)) the product lot number was not reported.Initial reporter - the customer contact information, including phone, fax, and e-mail address, 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) and the 1.5mm x 3cm deltaplush 10 (cpl10015330/unk lot) and decided to remove the coils from the patient; however, while resheathing the coils, the introducers failed to be rezipped.The coils were replaced with same-like coils, 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 2cm deltapaq was returned for evaluation.The device was returned completely zipped.The resheathing tool was seen slightly bent; however, no fractures were detected.The embolic coil was seen in the green introducer.There was a slight kink on the device positioning unit (dpu) core wire at the strain relief valve.The coil was then advanced from the introducer sheath and inspected under a microscope.The articulating joint was intact.The distal outer sheath had not softened, indicating that the detachment process had not been initiated.The embolic coil distal ball tip was missing from the distal end of the coil.No ball tip was returned.The length of the coil was measured approximately 2 cm, which aligns with the length from the product description.The v-notch of the resheathing tool was seen undamaged.The device was then completely unzipped and rezipped successfully.No protrusions from the introducer were detected.The sterile lot number was not reported; therefore, a review of the manufacturing documentation could not be performed.The customer report of rezipping difficulty was not confirmed.The device was successfully unzipped and rezipped.The complaint of positioning difficulty cannot be confirmed because positioning difficulty is specific to both procedure and situation and cannot be reproduced or tested in the lab.However, the dpu core wire was slightly kinked, and kinks in the dpu core wire can lead to positioning difficulty.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 kink in the dpu core wire.The coil was able to be advanced from its introducer sheath and form its secondary shape without any issue.There is not enough information to identify the cause of the failure.It is also unknown at what point the distal ball tip became removed from the embolic coil and whether it caused or was a result of the positioning difficulties that were claimed.100% of devices are inspected in-process for embolic coil damage and 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 damages.While the sequence of events leading to the observed missing distal ball tip cannot be determined based on the condition of the returned device, damage to the embolic coil typically occurs when an excessive retraction force is applied in the presence of resistance.The instructions for use (ifu) instructs on proper positioning of the microcoil system.The ifu also warns: ¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system¿ the device does not present any obvious indication of manufacturing defect or anomaly that could have contributed to the event as reported.Positioning difficulty, resheathing difficulty, and coil damage are known potential failures associated with the use of the device.The 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 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 3008114965-2019-00864 & 3008114965-2019-00865.
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) and the 1.5mm x 3cm deltaplush 10 (cpl10015330/unk lot) and decided to remove the coils from the patient; however, while resheathing the coils, the introducers failed to be rezipped.The coils were replaced with same-like coils, and the procedure was completed successfully.There was no report of consequence or impact to the patient.Evaluation of the returned devices revealed embolic coil damage.Multiple attempts were made without success to obtain additional information.

• Brand Name: DELTAPAQ CERE 1.5MMX2CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8233721
• Report Number: 3008114965-2019-00865
• Device Sequence Number: 18883038
• Product Code: HCG
• UDI-Device Identifier: 00878528007012
• UDI-Public: 00878528007012
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K080437
• 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): 10/14/2018

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: CDF10015230
• 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: 01/08/2019
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1