MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAPAQ CERE 4MMX10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10041030

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Based on the product analysis completed on 3/21/2018, this product event has been deemed fda mdr reportable.Procode: krd/hcg.Physical manufacturer name: (b)(4).Concomitant med products: presidio 10 cere 4mmx11.5cm ((b)(4)) thermo-mechanical coil.(b)(6).Physical manufacturer name: (b)(4).As reported by a healthcare professional, abnormal friction was encountered between the coil introducer and coil delivery system of a 4mm x 10 cm deltapaq ((b)(4)/ (b)(4)) and a 4mm x 11.5 cm presidio 10 ((b)(4)/unknown lot).It is not known how the procedure was completed or if there was any injury to the patient.No further information was provided.The product was returned for analysis.The distal end of the embolic coil was located in the green introducer.There was a kink in the device positioning unit (dpu) core wire approximately 97 cm from the proximal end.This portion of the dpu was sheathed.The dpu core wire protruded from the skive of the translucent introducer sheath at the kink.There was a bend in the sheathed portion of the dpu approximately 162 cm from the proximal end.There were bends in the unsheathed portion of the dpu core wire at the strain relief and approximately 13 cm, 23 cm, 48 cm, and 84 cm from the proximal end.The ball tip was intact.There was blood on the embolic coil.The embolic coil was kinked.The condition of the articulating joint and resistance heating (rh) coil was obscured by the translucent introducer sheath.The v-notch of the resheathing tool was undamaged.The kinks in the embolic coil and the sheathed portion of the dpu core wire prevented the device from advancing or retracting.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 of resistance or friction with the introducer was confirmed.The kinked embolic coil and kinks in the dpu core wire prevented the device from advancing or retracting.The observed kinks and bends in the dpu core wire are evidence that excessive force was applied to the device, possibly in an attempt to overcome reported resistance.Resistance could have been caused by insufficient flush.The presence of blood on the embolic coil suggests that an insufficient flush was maintained.The 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 cause of the kink in the embolic coil cannot be determined from the condition of the returned device.The kink in the embolic coil could have contributed to the reported resistance, or it could have resulted from the application of excessive force.100% of devices are inspected at final assembly by advancing the embolic coil out of the introducer and retracting it back in.Damage to the embolic coil would be rejected at this point.Therefore, it is unlikely that the device left the manufacturing facility with the observed kink in the embolic coil.With review of the product 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 unit.Although a definitive conclusion cannot be made, it appears that procedural factors addressed in the instructions for use may have contributed to the event and 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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2018-00580 & 3008114965-2018-00581.

Event Description

As reported by a healthcare professional, abnormal friction was encountered between the coil introducer and coil delivery system of a 4mm x 10 cm deltapaq cere (cdf10041030/ c23252) thermo-mechanical coil and a 4 mm x 11.5 cm presidio 10 cere (pc410041230/unknown lot) thermo-mechanical coil.It is not known how the procedure was completed or if there was any injury to the patient.No further information was provided.

• Brand Name: DELTAPAQ CERE 4MMX10CM
• 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: 7372773
• MDR Text Key: 103667660
• Report Number: 3008114965-2018-00580
• Device Sequence Number: 1
• Product Code: HCG
• 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: 12/17/2017

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: 12/31/2018
• Device Catalogue Number: CDF10041030
• Device Lot Number: C23252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2014
• 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