MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAMAXX SR PLAT 18SYS 6X25; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DMX18062520
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Material Deformation (2976); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Due to the clinically significant delay in procedure (1 hour), the event has been classified as a "serious injury".Procode: krd/hcg.Physical manufacturer name: (b)(4).The product is available for evaluation and testing; however, it has not been received to date (which is indicated as "other").Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
A report was received that the size of the 6x25 deltamaxx 18 (dmx18062520/c30717) stretch-resistant thermo-mechanical coil was deemed unsuitable for the target lesion and during its removal from the patient, the device separated in the unspecified microcatheter.The coil and microcatheter were removed as a unit.The unspecified guiding catheter was displaced because of the manipulation, which ultimately lead to the reinsertion of the guiding catheter and microcatheter.The surgery was delayed one hour due to the event.The event also resulted in the usage of new products.There was no report of consequence or impact to the patient.The device will be returned for evaluation.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: a report was received that the size of the 6x25 deltamaxx 18 (dmx18062520/c30717) stretch-resistant thermo-mechanical coil was deemed unsuitable for the target lesion and during its removal from the patient, a part of the product broke/detached in the unspecified microcatheter.The coil and microcatheter were removed as a unit.The unspecified guiding catheter was displaced because of the manipulation, which ultimately lead to the reinsertion of the guiding catheter and microcatheter.The surgery was delayed one hour due to the event.The event also resulted in the usage of new products.No patient complications occurred as a result of the event.Multiple attempts to obtain additional information were unsuccessful.The 6x25 deltamaxx 18 was returned for evaluation.The embolic coil was stretched and detached from the device positioning unit (dpu); it was returned tangled around the dpu.The embolic coil was gently disentangled from the dpu.The device was fully unsheathed.The resheathing tool had been advanced past the proximal end of the green introducer.The dpu had been fully advanced through the introducer.The resheathing tool was broken.There was a kink in the flexible tip coil section of the dpu.The ball tip was present and intact.The embolic coil was kinked and stretched.There was blood on the embolic coil.The proximal loop and solder ring were present, indicating that the embolic coil was complete.The detachment fiber had been pulled out of the distal outer sheath and broken.The resistance heating (rh) coil had not heated.There was a minor amount of plastic remodeling damage to the v-notch of the resheathing tool.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the embolic coil detached prematurely was confirmed.The embolic coil was returned complete, as shown by the presence of both the ball tip and the proximal loop.However, the embolic coil was detached from the dpu.Since the rh coil had not been heated and the detachment fiber has been pulled from the distal outer sheath and broken, the embolic coil detached mechanically.Mechanical detachment and stretching of the embolic coil generally occur when excessive retraction force is applied to the device in the presence of resistance.The exact circumstances surrounding the reported event are unknown, and no definitive cause of resistance can be identified from the condition of the returned device.The embolic coil was kinked as well as stretched.This damage could have caused resistance; it could have been caused by the same application of force that resulted in the stretching and detachment of the embolic coil, or it could have occurred after the reported event, during storage and/or return of the device.100% of devices are inspected for damage to the embolic coil at final assembly.Thus, it is very unlikely that the device left the manufacturing facility with any of the observed damage.It is possible that clinical/procedural factors and the concomitant microcatheter may have contributed to the reported failure; however, due to the lack of procedural information and based on the analysis, a definitive root cause conclusion regarding the reported event cannot be determined.With review of the analysis and the device history records, there is no indication of any device manufacturing or design issues related to the reported event or 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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: DELTAMAXX SR PLAT 18SYS 6X25
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7525056
• Report Number: 3008114965-2018-00626
• Device Sequence Number: 11119111
• Product Code: KRD
• UDI-Device Identifier: 10878528001710
• UDI-Public: 10878528001710
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K120274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: DMX18062520
• Device Lot Number: C30717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 04/28/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other