MAUDE Adverse Event Report: SEE H.10 MSPHERE 10 CERE, 2MMX2.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CSP10020030
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No:(b)(4).Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).Initial reporter information such as phone and email address are not available / reported.[conclusion]: the healthcare professional reported that during the procedure, the physician reported that strong resistance was encountered during the advancement of the 2mm x 2.5cm micrusphere 10 cerecyte coil (csp10020030 / s11413) through the prowler lpes microcatheter.The physician replaced the coil with another micrusphere 10 cerecyte coil and the procedure was successfully completed without further issue or delay.There was no report of patient injury or adverse event.Multiple attempts were made to obtain additional information and details related to the procedure, however, additional information was not available.The 2mm x 2.5cm micrusphere 10 cerecyte coil was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: the 2mm x 2.5cm micrusphere 10 cerecyte coil was received contained a pouch.The packaging label was not returned.The device was inspected; no damage was observed on the hub.The device positioning unit (dpu) core wire was inspected and was found without any damage.The green coil introducer was inspected and was noted to be fully sheathed and without damage.The embolic coil was in the introducer.The v-notch of the resheathing tool, the ball tip and the articulating joint were inspected under the microscope.All components were without any damage.The embolic coil was observed to be stretched.The embolic coil was advanced through the introducer and resistance friction was encountered when it passed through the introducer.The resistance could have been the cause of the stretched condition of the coil.A review of manufacturing documentation associated with this lot (s11413) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The issue reported in the complaint that the coil encountered strong resistance during advancement was confirmed.The embolic coil was also found stretched, likely due to applied excessive force.Devices undergo 100% in-process inspection to check for the advancement of the embolic coil as well as the condition of the coil.It is unlikely that the 2mm x 2.5cm micrusphere 10 cerecyte coil left the manufacturing facility with the embolic coil in a stretched condition.Coil damage such the stretched condition of the embolic coil noted on the returned micrusphere 10 cerecyte coil is a known potential issue associated with the use of this device.The ifu contains instructions on proper handling of the device.The resistance reported in the complaint when the coil was being advanced was confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the resistance issue could not be conclusively determined.Devices undergo in-process verification of functionality such as coil advancement.The issue would have been caught during final assembly.The cause of the stretched coil condition was also not conclusively determined, however, likely it was the result of excessively force inadvertently applied during the attempt to advance the coil during the procedure that could have contributed to the coil becoming stretched.It is also possible that clinical and procedural factors including device manipulation / interaction, aneurysm size/vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported resistance during advancement issue and ultimately resulted in the force unknowingly applied on the coil causing it to become stretched.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.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the procedure, the physician reported that strong resistance was encountered during the advancement of the 2mm x 2.5cm micrusphere 10 cerecyte coil (csp10020030 / s11413) through the prowler lpes microcatheter.The physician replaced the coil with another micrusphere 10 cerecyte coil and the procedure was successfully completed without further issue or delay.There was no report of patient injury or adverse event.Multiple attempts were made to obtain additional information and details related to the procedure, however, additional information was not available.

• Brand Name: MSPHERE 10 CERE, 2MMX2.5CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8165076
• Report Number: 3008114965-2018-00839
• Device Sequence Number: 1997165
• Product Code: HCG
• UDI-Device Identifier: 00878528001003
• UDI-Public: 00878528001003
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K0022420
• 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): 03/27/2018

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 Expiration Date: 07/31/2021
• Device Catalogue Number: CSP10020030
• Device Lot Number: S11413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1