MAUDE Adverse Event Report: SEE H.10 DELTAPL CERE COIL 10 SYS 1.5X3; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number CPL100153-30

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Physical manufacturer name: (b)(4).Concomitant med products: unknown brand microcatheter.The initial reporter address is not available; the initial reporter phone is (b)(6); the initial reporter email is not available.Physical manufacturing site name: (b)(4).Additional information will be submitted within 30 days of receipt.Investigation summary: the device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The embolic coil and device positioning unit (dpu) have been removed from the introducer.Both pieces (embolic coil attached to dpu, introducer) were returned.There are no apparent kinks or bends in the dpu core wire.The ball tip is missing.The embolic coil is stretched.The suture filaments are not visible in the articulating joint.The resistance heating (rh) coil has not heated.The v-notch of the resheathing tool is undamaged.The embolic coil was gently uncoiled and the length was estimated with ruler 70007-02ex.The embolic coil is longer than 3 cm long, including the stretched section.Advancement cannot be tested because the embolic coil has been removed from the introducer.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.Conclusion: the complaint that the device is impeded in the microcatheter cannot be confirmed.As returned, the embolic coil and dpu have been removed from the introducer.Once the introducer has been removed from the device, it cannot be replaced, so advancement through a microcatheter cannot be tested.The returned embolic coil is stretched.Stretching occurs when excessive retraction force is applied to the device while it is prevented from retracting.While the exact circumstances of the event are unknown, the evidence that the ball tip is missing from the embolic coil suggests that the distal end of the device was lodged at some point, and excessive force was applied to retract it, causing the embolic coil to stretch and the ball tip and suture filaments to remain behind.The exact length of the returned embolic coil cannot be precisely measured since the coil is stretched and not contained within the introducer.However, as an estimate, the returned embolic coil is within the specified length of 3.0 ± 0.5 cm per pic-cspec55666 rev.6.Since the stretched section of the embolic coil is at the proximal end, and since there is no other apparent damage to the distal end of the embolic coil, it is likely that the entire embolic coil was returned, and only the ball tip was separated from the device.A 100% of devices are inspected for the dimensions and condition of the ball tip at final quality control (qc) inspection per the cited pic-cspec document, so it is very unlikely that the ball tip was missing from the device when it left the manufacturing facility.Device history lot: a review of manufacturing documentation associated with this lot (c41244) 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.

Event Description

The healthcare professional reported that during the coil embolization procedure of an unknown target site, the deltapl cere coil 10 sys 1.5 x 3 (cpl10015330 / c41244) could not be advanced through the microcatheter (unknown brand).The coil was withdrawn and a new coil was used to complete the procedure using the same microcatheter.The coil did not kink or bend at any time prior to the resistance/friction.The concomitant devices used with the deltapl cere did not kink or bend at any time.When the coil was removed from the patient, there were no damages on any part of the device.Adequate continuous flush was maintained through the catheter.There was no report of patient injury.No additional information is available.

• Brand Name: DELTAPL CERE COIL 10 SYS 1.5X3
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont 94538
• Manufacturer (Section G): SEE H.10; 47709 fremont blvd; fremont CA
• Manufacturer Contact: gabriel alfageme ; chemin-blanc 38; le locle neuchatel CH-24-00 ; SZ CH-2400 ; 949789-868
• MDR Report Key: 7393885
• MDR Text Key: 104549022
• Report Number: 3008114965-2018-00586
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008194
• UDI-Public: (01)00878528008194(11)160302(17)210228(10)C41244
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: CPL100153-30
• Device Catalogue Number: CPL10015330
• Device Lot Number: C41244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• Date Device Manufactured: 03/02/2016
• 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