MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX - PLATINUM MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number DMX18185520

Device Problems Stretched (1601); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

Common device name: krd/hcg.This complaint met mdr reporting criteria on 5/4/2017 when the analysis found coil stretching and buckling.Conclusion: lot c19940 was returned for analysis.There was unreported damage of the resheathing tool being returned severed and off the introducer sheath with the distal section of the resheathing tool not being returned.The resheathing tools fracture is ductile in nature requiring external force.No material defects were found.Unreported damage of the device positioning unit (dpu) protruding outside the sheath located 78.5 centimeters off the distal tip of the green introducer.No sheath damage was found at the protrusion site.The proximal section of the coil has unreported stretching and buckling damage.The remainder of the coil is undamaged.No manufacturing defects were found.The circumstances of how and when all the unreported damage occurred cannot be determined.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 resheathing difficulty was confirmed; however, there was confirmed unreported stretching and buckling of the coil.Due to multiple unreported damages found, and the failure to return the distal section of the resheathing tool, the root cause of the resheathing difficulty cannot be determined; however, the evidence as received highly suggests that the coil had to have been advanced when the dpu protruded outside the sheath which also may have produced the coil damage found.The most likely contributing factor of the coil protruding outside the sheath which prevented the resheathing appears to be, in part, interference in the form of a binding action or an anchoring effect.The unknown interference most likely caused the dpu to protrude outside the sheath which prevented the resheathing of the unit.In addition, without the return of the distal severed section of the resheathing tool, the identification or the return of the unknown microcatheter and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.Since there was no evidence of a manufacturing issue found during the analysis, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional during coil embolization of an endoleak, a deltamaxx (dmx18185520/ c19940) could not be re-sheathed and analysis revealed the proximal section of the coil had unreported stretching and buckling damage, and there was a lot of tension when attempting to advance a deltamaxx (dmx18165020/ c18057) from the sheath.The first coil had been advanced into the sac, but the doctor did not like the catheter position.They attempted to re-sheath the coil, but the coil could not be re-sheathed.The second coil was advanced, but the doctor did not like the shape it was taking, so the coil was successfully re-sheathed to reposition the catheter.When they attempted to un-sheath the second coil, they felt a lot of tension when trying to advance the coil from the sheath.They exchanged the coil to a different coil.Neither of the devices appeared to be visibly damaged in any way.There were no adverse patient issues.

• Brand Name: DELTAMAXX - PLATINUM 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: 6557277
• MDR Text Key: 74997255
• Report Number: 2954740-2017-00101
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10878528001833
• UDI-Public: (01)10878528001833(17)180721(10)C19940
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2018
• Device Catalogue Number: DMX18185520
• Device Lot Number: C19940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1