MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAPL CERE COIL 10 SYS 2X3; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CPL10020330

Device Problems Fracture (1260); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Based on the product analysis completed on (b)(6) 2018, this product event now meets the criteria for medical device reporting (mdr).Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).Initial reporter phone, fax, and e-mail were not reported.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).Complaint conclusion: as reported by a healthcare professional, the physician encountered strong resistance while advancing the 2x3 deltaplush ((b)(4)) thermo-mechanical detachable coil delivery system through the prowler lpes microcatheter.The coil delivery system got stuck and could no longer advance.The procedure was completed successfully with a same-like coil.There was no loss of cerebral target position.No patient complications occurred as a result of the event.The product was stored and prepped according to the instructions for use (ifu).Prior to this coil, 4-5 coils went through the same microcatheter without resistance.There were no kinks noted in the microcatheter that may have contributed to the event.An adequate continuous flush was maintained through the microcatheter.No visible product damage was noted.No further information was provided.The device was returned for analysis.The embolic coil passed through the resheathing tool.The device positioning unit (dpu) core wire was kinked approximately 38 cm from the proximal end.There was a slight bend in the dpu core wire approximately 98 cm from the proximal end.The ball tip was present, but was partially detached from the distal end of the embolic coil.The embolic coil passed into the resheathing tool.The visible portion of the embolic coil was kinked.The embolic coil, articulating joint, and resistance heating (rh) coil were visible in the opening of the resheathing tool.The visible portion of embolic coil was kinked.The articulating joint was intact.The rh coil had not been heated.The v-notch of the resheathing tool was undamaged.Advancement could not be tested because the embolic coil was partially unsheathed in the opening 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 device was impeded in the microcatheter was confirmed.While the embolic coil could not be advanced or retracted in the introducer, the observed damage to the embolic coil would also prevent it from advancing through a microcatheter.The embolic coil was kinked, the ball tip was partially detached, and the dpu core wire was kinked, all of which are indicative of the application of excessive force, possibly an attempt to overcome the reported resistance.The microcatheter in use during the reported event was not returned.Without the return of the microcatheter, the cause of the resistance could not be determined.The resheathing tool had passed over the embolic coil.Based on the event description, this may have occurred during retraction of the device after the event.When the embolic coil passes through the resheathing tool and is unsheathed, it is likely to become anchored in the skive of the translucent introducer sheath, and cannot be advanced or retracted.Unsheathing the embolic coil can also result in damage to the embolic coil and the fragile distal end of the dpu.With review of the analysis and the device history records, there is no indication of any manufacturing issues related to the reported event or damages noted on the returned system.Although a definitive conclusion cannot be made, based on the analysis it appears that procedural and handling factors may have contributed to the reported failure and damages observed 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.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.

Event Description

As reported by a healthcare professional, the physician encountered strong resistance while advancing the 2x3 deltaplush ((b)(4)) thermo-mechanical detachable coil delivery system through the prowler lpes microcatheter.The coil delivery system got stuck and could no longer advance.The procedure was completed successfully with a same-like coil.There was no loss of cerebral target position.No patient complications occurred as a result of this event.The product was stored and prepped according to the instructions for use (ifu).Prior to this coil, 4-5 coils went through the same microcatheter without resistance.There were no kinks noted in the microcatheter that may have contributed to the event.An adequate continuous flush was maintained through the microcatheter.No visible product damage was noted.No further information was provided.

• Brand Name: DELTAPL CERE COIL 10 SYS 2X3
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• Manufacturer (Section G): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; chemin-blanc 38; le locle neuchatel CH-24-00 ; SZ CH-2400 ; 949789-868
• MDR Report Key: 7451746
• MDR Text Key: 106980342
• Report Number: 3008114965-2018-00603
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008200
• UDI-Public: 00878528008200
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/02/2018

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: 11/30/2021
• Device Catalogue Number: CPL10020330
• Device Lot Number: S12818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1