MAUDE Adverse Event Report: DELTAPL CERE COIL 10 SYS 1.5X2; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CPL10015230

Device Problems Kinked (1339); Stretched (1601); Physical Resistance (2578); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
=
> (b)(4).Udi: (b)(4).The lot number could not be obtained; therefore, the manufacture and expiration dates of the device could not be determined.Initial reporter: the customer information could not be obtained.The event occurred in (b)(6).Manufacturer name: (b)(4).The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during a coil embolization procedure, the third coil, a deltaplush (cpl10015230/lot unk) could not be advanced when filling the aneurysm.They withdrew the coil with the microcatheter and used another coil to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.

Manufacturer Narrative

Product complaint # (b)(4).The device was returned on 12/7/2017 instead of 12/8/2017 as previously reported.Additional information was received on 12/20/2017: the lot number of the device was not available.The procedure was embolization of an intracranial aneurysm.The device lot number, size and brand of microcatheter, vessel characteristics and patient demographics could not be obtained.Neither of the devices appeared damaged during the procedure.It was unknown how far the deltaplush had advanced through the microcatheter when the resistance was met; however, the coil had not exited the microcatheter into the patient.A continuous flush had been maintained through the microcatheter, and the devices had been prepped and used as per the ifu.Upon removal the device, the coil was still attached to the dpu.Customer information obtained and added to section e.Customer phone number: (b)(6).Additional information will be obtained within 30 days of receipt.

Manufacturer Narrative

Product complaint # (b)(4).Conclusion: as reported by a healthcare professional, during a coil embolization of an intracranial aneurysm, the third coil, a deltaplush (cpl10015230/lot unk) could not be advanced when filling the aneurysm and during product analysis, the coil was found to be kinked and stretched.They withdrew the coil with the microcatheter and used another coil to complete the procedure.There was no report of patient injury.Neither of the devices appeared damaged during the procedure.It was unknown how far the deltaplush had advanced through the microcatheter when the resistance was met; however, the coil had not exited the microcatheter into the patient.A continuous flush had been maintained through the microcatheter, and the devices had been prepped and used as per the ifu.Upon removal the device, the coil was still attached to the dpu.The device lot number, size and brand of microcatheter, vessel characteristics and patient demographics could not be obtained.The deltaplush was returned for analysis.The embolic coil and device positioning unit (dpu) have been removed from the introducer and returned separately.There were no apparent kinks or bends in the dpu core wire.The ball tip was intact.The embolic coil was kinked and stretched.The articulating joint was intact.The resistance heating (rh) coil had not heated.The v-notch of the resheathing tool was undamaged.Since the introducer has been removed from the device, neither advancement through the introducer nor advancement through a microcatheter can be tested.The lot number of the device was unknown.Without the lot number, the manufacturing information could not be reviewed.The complaint that the device was impeded in the microcatheter could not be confirmed.The dpu with the embolic coil attached was removed from the introducer, and the two parts of the device were returned separately.The embolic coil cannot be re-inserted through the introducer to test advancement.The embolic coil was kinked and stretched.While the exact circumstances surrounding the event are not known, a damaged embolic coil could experience friction in the microcatheter.This type of damage could alternatively have been caused during an attempt to overcome friction, or after removal from the microcatheter, or during product return (especially since the coil was not enclosed in the introducer when returned).100% of devices are inspected in-process for damage to the embolic coil, so it is unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.There is no current safety signal identified related to the reported events based on review of complaint histories for the device.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.

• Brand Name: DELTAPL CERE COIL 10 SYS 1.5X2
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7122298
• MDR Text Key: 95791931
• Report Number: 3008114965-2017-00510
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2017

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 Catalogue Number: CPL10015230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 11/21/2017; 11/21/2017
• Supplement Dates FDA Received: 01/12/2018; 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1