MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX - PLATINUM MICROCOIL; CNV DCS COILS

Catalog Number DMX18041520

Device Problems Knotted (1340); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of one initial report being submitted for this complaint (b)(4).(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.

Event Description

As reported by a healthcare professional, during the coil embolisation procedure at an unknown target site, the deltamaxx microcoil (dmx18041520/ c12262) failed to detach.It is unknown if the event resulted in additional medical intervention or surgical delay.It is unknown if there were any patient complications due to the event.

Manufacturer Narrative

This is one of one final mdr report being submitted for this complaint.Unreported product damage noted on the returned product, it is unknown when the damage occurred.Added additional device code of "knotted" to report the coil damage.The unidentified detachment control box (dcb), the unknown connecting cable and the unidentified microcatheter were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned/rinsed before being returned which may have produced further damage.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.As viewed through the returned packaging unreported damage of the exposed and unsheathed coil being entangled, knotted, and damaged was found damage was found to the proximal section of the coil.Due to post-procedural cleaning, handling, and packaging, the circumstances of how and when the unreported coil damage occurred cannot be determined.The distal section of the coil was found to be undamaged.The detachment fiber was returned undamaged, intact, and did not receive heat and melt.The device positioning unit (dpu) passed electrical testing with resistance at 54.9 ohms (range 48.5/56.0) and the enpower dcb systems ready green light illuminated (ifu).The coil detached on the first detachment cycle.Post-detachment inspection found that the enpower systems ready green light remained illuminated and the resistance passed at 54.9 ohms.Post-detachment inspection found that the detachment fiber received heat and melted as designed.The field complaint of the coils non-detachment could not be duplicated.No manufacturing defects were found.The complaint of the coils non-detachment cannot be confirmed.The dpu passed electrical testing and detached the coil on the first detachment cycle; therefore the root cause of the coils non-detachment cannot be determined.It was not stated that a pre-deployment electrical test was completed.If the pre-deployment electrical test was not completed, then for optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿verify the functionality of the microcoil delivery system before proceeding with microcoil placement.This needs to be done with the microcoil still in the hoop.To verify proper dcb and microcoil functionality a connecting cable and microcoil must be connected to the dcb unit.After verification of the dcb and connecting cable, turn off power to the dcb and disconnect the connecting cable from the microcoil until the microcoil is ready to be detached.Please refer to the detachment control box instructions for use section, located near the end of this document, before proceeding.¿ in addition, without the return of the complete detachment system and the identification or the return of the unknown microcatheter used in the procedure, it cannot be determined if these components contributed to the complaint event.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The complaint of the coil¿s non-detachment cannot be confirmed.The dpu passed electrical testing and detached the coil on the first detachment cycle; therefore the root cause of the coils non-detachment cannot be determined.Without the return of the complete detachment system and the identification or the return of the unknown microcatheter used in the procedure, it cannot be determined if these components contributed to the complaint event.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.Product was returned for analysis on 29mar16.Previously reported as not being returned.

Manufacturer Narrative

This is one of one follow-up # 2 for this complaint.Updated event description with the information received.

Event Description

As reported by a healthcare professional, during the coil embolization procedure at an unknown target site, the deltamaxx microcoil ((b)(4)) failed to detach.There were no surgical delays or patient consequences due to the reported event the product is available for analysis.

• Brand Name: DELTAMAXX - PLATINUM MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: kimberly soter ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 5477164
• MDR Text Key: 39585756
• Report Number: 2954740-2016-00054
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120274
• 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,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: DMX18041520
• Device Lot Number: C12262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1