MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAPAQ CERE 2MMX6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10020630

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Based on the product analysis completed on 4/17/2018, 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)).Complaint conclusion: as reported by a healthcare professional, the physician encountered strong resistance advancing the 2mm x 6cm deltapaq (cdf10020630/ s11810) thermo-mechanical detachable coil delivery system through the prowler lpes microcatheter.The coil delivery system got stuck and could no longer advance.The coil was replaced and the procedure was completed successfully.The prowler lpes microcatheter was not removed with the coil.The same microcatheter was used to complete the case; therefore, there was no loss of cerebral target position associated with this issue.No patient complications occurred as a result of the event.The product was stored and prepped according to the instructions for use (ifu).Approximately 3-4 coils were advanced through the same microcatheter prior to this coil.An adequate continuous flush was maintained through the catheter.No further information was provided.The device was returned for evaluation.The embolic coil was located in the translucent introducer sheath.The device was fully sheathed.There was a bend in the (dpu) core wire approximately 88 cm from the proximal end.The ball tip was intact.The embolic coil was kinked.The articulating joint was compressed longitudinally.The condition of the (rh) coil was obscured by the translucent introducer sheath.The v-notch of the resheathing tool was undamaged.An attempt was made to advance the embolic coil out of the introducer.The embolic coil could not be advanced or retracted.Since the embolic coil could not be advanced out of the introducer, advancement through a microcatheter could not be tested.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 and the articulating joint was compressed longitudinally.This is indicative of the application of excessive force, possibly an attempt to advance the device against an impediment or blockage.The impediment is not observed in the returned device.The microcatheter in use during the reported event was not returned.However, according to the updated event description, the microcatheter was successfully used to complete the procedure, suggesting that there was no blockage present in that device.The ifu cautions, ¿if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.¿ it is possible that the end of the introducer was not well seated in the hub of the microcatheter, and the observed damage occurred as the embolic coil was advanced through the hub of the microcatheter.100% of devices are inspected during final assembly by advancing the embolic coil out of the introducer and retracting it back in.Thus, it is unlikely that the embolic coil left the manufacturing facility with the observed damage.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.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 advancing the 2mm x 6cm deltapaq thermo-mechanical detachable coil delivery system (cdf10020630/ s11810) through the prowler lpes microcatheter.The coil delivery system got stuck and could no longer advance.The coil was replaced and the procedure was completed successfully.The prowler lpes microcatheter was not removed with the coil.The same microcatheter was used to complete the case; thus, there was no loss of cerebral target position associated with the issue.No patient complications occurred as a result of the event.The product was stored and prepped according to the instructions for use (ifu).Approximately 3-4 coils were advanced through the same microcatheter prior to this coil.An adequate continuous flush was maintained through the catheter.The associated microcatheter was discarded and thus is not available for return.No further information was provided.

• Brand Name: DELTAPAQ CERE 2MMX6CM
• 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: 7451740
• MDR Text Key: 106266976
• Report Number: 3008114965-2018-00602
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007098
• UDI-Public: 00878528007098
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K080437
• 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: 02/01/2018

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: 08/31/2021
• Device Catalogue Number: CDF10020630
• Device Lot Number: S11810
• 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: 09/27/2016
• 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