MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASHMERE 14 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CRC14040830

Device Problems Positioning Failure (1158); Kinked (1339); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was returned for analysis; however, the analysis has not yet been completed.Three attempts to obtain additional information were unsuccessful.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during the procedure, the cashmere coil (crc14040830/ s10006) could not be detached.They exchanged the coil to complete the procedure.There was no report of patient injury.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, during the procedure, the cashmere coil (crc14040830/ s10006) could not be detached.They exchanged the coil to complete the procedure.There was no report of patient injury.Multiple attempts to obtain additional information were unsuccessful.The cashmere was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The distal end of the embolic coil is located in the green introducer near its distal end.There appears to be blood on the embolic coil.The resheathing tool is broken.There is a kink in the device positioning unit (dpu) core wire at the strain relief and a bend approximately 2 cm from the strain relief.The ball tip is intact.The embolic coil is kinked in several locations and stretched.The articulating joint and resistance heating (rh) coil are obscured by the green introducer.However, the articulating joint appears to be damaged.There is blood visible in the green introducer and translucent introducer sheath.An attempt was made to advance the embolic coil out of the introducer to visualize the articulating joint and rh coil.The damaged embolic coil could not be advanced.While the resheathing tool is broken, its v-notch is undamaged.The resistance of the device was measured and the resistance was 52.8, which is within the specification range of 48.5  56.The device was connected to lab sample detachment control box (b)(4) with a standard connecting cable and the power was turned on.The system ready light illuminated.Detachment functionality cannot be tested because the embolic coil cannot be advanced out of 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.The complaint that the embolic coil failed to detach cannot be confirmed.While the embolic coil is attached to the dpu, and it passes the resistance test and causes the system ready light on the dcb to illuminate, the embolic coil cannot be advanced out of the introducer to test the detachment cycle.The kink and bend in the dpu core wire, broken resheathing tool, kinked embolic coil, and damaged articulating joint are all evidence that excessive force was applied to the device, possibly in an attempt to overcome resistance during advancement.The presence of blood in the green introducer and translucent introducer sheath suggests that an insufficient flush was maintained.The instructions for use (ifu) states that continuous infusion of an appropriate flush solution is optimal performance, and also 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.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: CASHMERE 14 - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6849322
• MDR Text Key: 85628488
• Report Number: 2954740-2017-00256
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528004486
• UDI-Public: (01)00878528004486(17)210331(10)S10006
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072173
• 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,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: CRC14040830
• Device Lot Number: S10006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1