MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAPL CERE COIL 10 SYS 1.5X2; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CPL10015230

Device Problems Material Separation (1562); Stretched (1601); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Based on the embolic coil damage noted during the product investigation, this event meets the required criteria for mdr reporting.Procode: krd/hcg.(b)(4).[complaint conclusion] as reported by a healthcare professional, during a coil embolization procedure, the 1.5mm x 2cm deltaplush cere 10 (cpl10015230/s10766) thermo-mechanical coil could not be advanced out of the unspecified microcatheter.The coil was removed from the microcatheter and replaced.The same microcatheter was used to complete the procedure.There was no report of a loss of cerebral target position.No patient complications occurred as a result of the event.No visible product damage was noted prior to the event or after removal from the patient.An adequate continuous flush was maintained through the microcatheter.No further information was provided.The 1.5mm x 2cm deltaplush cere 10 was returned for evaluation.The returned package label matched the complaint information.As returned, the introducer was removed from the device positioning unit (dpu).The embolic coil could be seen inside the translucent introducer proximal to the resheathing tool, unattached to the dpu core wire.The dpu core wire was kinked at approximately 35 cm and 76 cm from the proximal end of the device.The distal outer sheath was observed to be slightly bent.The resistance heating coil had not been heated, as indicated by the condition of the distal outer sheath.The embolic coil proximal connector loop was seen connected to the articulating joint, but the embolic coil was broken off just distal to the connector loop.Foreign substance was found in the introducer and upon further examination it was determined to be dried blood.The v-notch of the resheathing tool was undamaged.The proximal end of the embolic coil was observed to be kinked, stretched, and separated from its proximal connector loop.The embolic coil was stretched and kinked approximately in the middle of its length.The distal end of the embolic coil was observed in the introducer and was positioned outside the introducer for a microscopic analysis.The distal ball tip was not present and was not returned.The coil could not be advanced due to its damaged condition.A review of manufacturing documentation associated with this lot 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 complaint of impeded in microcatheter could not be confirmed due to the condition of the returned device.In addition, the concomitant microcatheter was not returned.The embolic coil was seen kinked and stretched at both its proximal end and in the middle of its length.The embolic coil was separated from the device without the rh coil being heated, not at its intended detachment zone.The stretching and kinks in the coil, the kinks in the dpu core wire, and improper coil detachment indicate excessive force was applied.The presence of blood in the introducer and around the embolic coil suggests that an insufficient flush was maintained.The instructions for use (ifu) states that continuous infusion of an appropriate flush solution is required for optimal performance and indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.100% of embolic coils are inspected for irregularities at the ball tip, along the length, and at the socket ring.Thus, it is unlikely that device left the manufacturing facility with the observed damage.The returned device did not present any obvious indication of manufacturing defect or anomaly that could have contributed to the event as reported.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and the evidence presented by the sample article; however, it is possible that procedural and handling factors, including device manipulation and the concomitant microcatheter, may have contributed to the reported failure and damages noted on 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.

Event Description

As reported by a healthcare professional, during a coil embolization procedure, the 1.5mm x 2cm deltaplush cere 10 (cpl10015230/s10766) thermo-mechanical coil could not be advanced out of the unspecified microcatheter.The coil was removed from the microcatheter and replaced.The same microcatheter was used to complete the procedure.There was no report of a loss of cerebral target position.No patient complications occurred as a result of the event.No visible product damage was noted prior to the event or after removal from the patient.An adequate continuous flush was maintained through the microcatheter.Evaluation of the returned sample revealed significant embolic coil damage.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections: phone.Initial reporter phone: (b)(6).The purpose of this mdr submission is to correct/update the facility address and customer contact details based on additional information provided by the affiliate on (b)(6) 2018.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: DELTAPL CERE COIL 10 SYS 1.5X2
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7926537
• MDR Text Key: 122645799
• Report Number: 3008114965-2018-00758
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008170
• UDI-Public: 00878528008170
• Combination Product (y/n): N
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: CPL10015230
• Device Lot Number: S10766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 10/07/2018
• Supplement Dates FDA Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1