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

Catalog Number DMX18104020

Device Problems Unsealed Device Packaging (1444); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2016

Event Type  malfunction  

Manufacturer Narrative

Device pro code: krd/hcg.It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Preliminary investigation found that there were no other complaints from (b)(6) for this lot number where the product was returned to the distribution center.At the time this device was manufactured, tamper proof labels were not applied to the outer box.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, a deltamaxx coil (dmx18104020/c10226) pouch was opened, and the coil was unraveled in the package.It was reported that the coil arrived in the packaging and was scanned into the system and put on the shelf.When they were ready to use the coil for the case, they found the coil was in its packaging, but the packaging was all taped up.The coil was unraveled in the package.It was reported that the pouch was never opened by any of the staff.There had been no recent coil unraveled complaints from the site.There was no report of the box being damaged.There were no adverse events or delay in the case.It was reported that the device would be returned for analysis.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, a deltamaxx coil (dmx18104020/c10226) pouch was opened, and the coil was unraveled in the package.It was reported that the coil arrived in the packaging and was scanned into the system and put on the shelf.When they were ready to use the coil for the case, they found the coil was in its packaging, but the packaging was all taped up.The coil was unraveled in the package.It was reported that the pouch was never opened by any of the staff.There had been no recent coil unraveled complaints from the site.There was no report of the box being damaged.There were no adverse events or delay in the case.It was reported that the device would be returned for analysis.The deltamaxx coil was returned for analysis.The external product box was not returned and the upper sticker identification label was also removed from the opened pouch.As viewed through the returned packaging, unreported findings found only a section of a severed microcatheter and a protruding stretched coil with a copious amount of blood on it.The device positioning unit (dpu) was not returned nor was it reported as to the circumstances of this occurrence, its separation from the coil, of its current location, and why it was not returned.The proximal section of the microcatheter was severed and not returned.This is unreported device damage.The returned severed microcatheter has been identified as most likely a sl-10 microcatheter from dimensions and its external features.It is confirmed that the pouch was returned taped at the top and left side.This tape is not used during the manufacture of the product as all pouches are completely sealed in order to retain the sterility of the product in a vacuum environment.This type of tape is not found inside the manufacturing facility and is not used in the production of this product.The opened and taped pouch would not have passed inspection prior to final packaging or during final packaging.The origin and the use of this tape most likely occurred at the hospital with the end user involved.The unreported damaged distal tip of the microcatheter with a blood plug and a stretched coil protruding outside was found.The stretched coil coated with an unreported copious amount of a blood and protein mixture was found along the entire length of the stretched coil.No manufacturing defects were found.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 pouch found open, taped, and the coil unraveled inside was confirmed.While the root cause cannot be determined, the evidence as received highly suggests that the most likely contributing factor to the pouch found open and taped with a stretched coil protruding out of an unreported severed section of the microcatheter with a copious amount of blood and protein mixture on the coil has the appearance of being from a possible unreported complaint that could have only occurred with the end user.There had been only one other previous compliant involving this lot number, and it had occurred at another hospital and it was confirmed that the device was not returned to the distribution center.The circumstances of how and when this damage and condition occurred to the microcoil unit and pouch cannot be determined as it was reported that there had been no recent coil unraveled complaints from the site.In addition, without further clarification from the end user, the exact circumstances that led to the severe damages found to the stretched and detached coil, the missing dpu, the open and taped pouch (the product box was not returned), and the severed microcatheter found inside the returned pouch, that led to all this damage cannot be determined.Furthermore, without the return of the missing dpu, the product box, and the severed proximal section of the microcatheter, it cannot be determined to what extent these components may have played in any possible unreported complaint.Since there was no evidence of a manufacturing related issue, no corrective actions will be taken at this time.

• 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: 5920449
• MDR Text Key: 53670145
• Report Number: 2954740-2016-00197
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10878528001758
• UDI-Public: (01)10878528001758(17)170309(10)C10226
• 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
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2017
• Device Catalogue Number: DMX18104020
• Device Lot Number: C10226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1