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

Catalog Number CDX18083530

Device Problem Knotted (1340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

This is initial/final mdr report submitted for this complaint with associated mfr# 2954740-2017-00194.Additional procode krd.(b)(4).Initial reporter postal code: (b)(6).Reporter phone# (b)(6).The embolic coil was found unsheathed and exposed from the introducer sheath approximately 27.5 cm and 42.0 cm from the distal top of the introducer.The proximal exposed portion of the coil was tangled in a mass around itself upon return.The proximal section introducer sheath was not completely zipped over the dpu core wire.The embolic coil protruded outside the introducer sheath slightly distal from its articulating junction with the dpu.There were no other damages noted on the device including the embolic coil and the distal ball tip was completely enclosed inside the introducer sheath.The complaint of the coil exposed from the introducer is confirmed.A section of the dpu core wire was unzipped as reported by the user however the position of the embolic coil suggests it was advanced during the unsheathing process.It is unknown how and when the tangled mass at the proximal end of the exposed embolic coil was formed however when the mass formed it could push against the introducer sheath walls causing the introducer sheath skive to open and expose the embolic coil.It is possible that external factors including distal interference could cause the coil to become entangled.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 coil entanglement found during analysis on the device may have occurred due external factors including distal interference.Based on the information and the analysis, the reported event of coil being exposed from the introducer was confirmed, however procedural factors likely contributed to the event.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, review of 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.This submission is related to a literature article discovered in an effort to support the cer submission process, as such, the associated time frame of event dates includes but is not limited to 20 years.These articles are being reviewed on a monthly basis for safety signals and will be followed by monthly trending assessments as well as pms reviews.

Event Description

As reported by a healthcare professional, during preparation a deltamaxx coil (cdx18083530/c41169) was exposed from the middle portion when the introducer sheath was unzipped.The coil was reportedly not damaged.The procedure was for an abdominal emergency case.The physician commented that the coil was not handled carelessly or with force.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush was maintained at all times.The product will be returned for investigation.No further information is available.Upon receiving the device, the proximal portion of the coil was entangled.It is unknown when this issue occurred.

• Brand Name: DELTAMAXX - 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: 6697732
• MDR Text Key: 79522123
• Report Number: 2954740-2017-00194
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10878528008597
• UDI-Public: (01)10878528008597(17)210131(10)C41169
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CDX18083530
• Device Lot Number: C41169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1