MAUDE Adverse Event Report: SEE H.10 DELTAPAQ CERE 2MMX2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDF10020230
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The product lot number is not available / not reported.The expiration date of the device is not known.The device manufacture date is not known as the product lot number of the device is not available / not reported.The healthcare professional reported that the enpower check lamp did not work.There was no report of any patient consequence.Multiple attempts were made to obtain additional information; however, no further information has been provided.The 2mm x 2cm deltapaq 10 cerecyte coil (cdf10020230 / lot# unknown) was returned for evaluation.The investigation finding is documented below.Investigation summary: the non-sterile 2mm x 2cm deltapaq 10 cerecyte coil was received contained in a pouch.The device was visually inspected.The hub and device positioning unit (dpu) were both found in normal, good condition.The resheathing tool was also found without any damage.The embolic coil was outside of the coil introducer tangled with the rest of the device.There is no evidence that the device was used in patient based on the initial visual inspection.The returned device underwent microscopic inspection.The coil introducer was observed to be kinked.The v-notch was found in normal, good condition.The resistance heating (rh) was not heated and noted to be without any damage.The articulation joint was also observed to be without damage.The embolic coil was observed to be kinked and in stretched condition.The resistance of the device was measured with a multimeter.The measured resistance was 51.2 ¿, which is within the specification range of 48.5 ¿ 56 ¿.The device was connected to detachment control box dcb000005-00 (dcb) with enpower connecting cable, and the power was turned on.The system ready light illuminated.The 2mm x 2cm deltapaq 10 cerecyte coil was connected to a lab sample enpower control cable, the control cable was then connected to a lab sample detachment control box and the power was turned on.The system ready light was illuminated, which indicates that the device was ready for deployment.The embolic coil was immersed in warm enzyme solution and the detach button was pressed.The embolic coil was detached, and the rh was inspected under the microscope which showed that the rh was heated.The coil did not have any issue related to its ability to detach.The device lot number was not available.The device history record (dhr) review could not be performed without the lot number.Based on the result of the functional testing performed on the returned device, the reported issue documented in the complaint that the enpower check lamp did not work was not confirmed.The returned device was connected to the lab detachment control box and the enpower control cable, the system ready light illuminated, and the embolic coil underwent detachment without issue.The detachment control box and the control cable that were used during the procedure were not returned with the coil, therefore, the exact cause of the reported issue could not be conclusively determined.It is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.The complaint did not report any issue with the kinked and stretched condition of the embolic coil.With very limited information documented and without the availability of additional information, it is not known when the observed kinked and stretched condition of the coil occurred.The lot number of the device is not known, therefore review of the device history record was not performed.Assignment of root cause for the condition of the coil remains speculative and inconclusive, based on the limited information provided.Clinical and procedural factors such as device manipulation / interaction, target vessel, target lesion characteristics, device selection and concomitant microcatheter may have caused the coil to become kinked and stretched.Coil kink and coil stretched are known potential issues associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue from occurring.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 2mm x 2cm deltapaq 10 cerecyte coil left the manufacturing facility with the embolic coil kinked and in stretched condition as was 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 of failure to detach 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.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that the enpower check lamp did not work.There was no report of any patient consequence.Multiple attempts were made to obtain additional information; however, no further information has been provided.The 2mm x 2cm deltapaq 10 cerecyte coil (cdf10020230 / lot# unknown) was returned for evaluation which revealed the embolic coil was kinked and in a stretched condition.Based on the product analysis completed on 3/8/2019, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: DELTAPAQ CERE 2MMX2CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8423110
• Report Number: 3008114965-2019-00959
• Device Sequence Number: 16657050
• Product Code: HCG
• UDI-Device Identifier: 00878528007067
• UDI-Public: 00878528007067
• 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): 07/16/2018

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: CDF10020230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1