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

Catalog Number	CDF10051030
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was received by codman neurovascular on (b)(6) 2017; however, the event did not meet mdr reporting criteria until (b)(6) 2017 when it coil stretching was found via product analysis.Conclusion: the deltapaq was returned for analysis.Unreported damage of the coil protruding outside the sheath was found.Unreported kinks on the dpu located 40.5 and 112.0 (both in centimeters) off the proximal end.There is no mechanical sheath damage at the protrusion site.The exposed proximal section of the coil has unreported stretching damage.There are two other unreported damaged sections of the coil at the proximal section located inside the sheath.The v notch of the re-sheathing tool has been severely fractured.The locking mechanism has indentation, compression and stretching damage.No manufacturing defects were found.The circumstances of how and when all the unreported damages 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 re-sheathing difficulty was confirmed.While the exact root cause of the re-sheathing difficulty cannot be determined, especially with unreported damages to the unit, the most likely contributing factor appears to be of a handling nature.The evidence as received highly suggests that one possibility of the handling being a contributing factor may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the v notch of the resheathing tool and became embedded.In addition, the locking mechanism may not have been fully disengaged off the core wire.The sheath also caught the v notches extended edges.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which may have bent the dpu in multiple places and caused portion of the coil damage.The bent dpu may have opened up the skive which would have allowed the dpu/coil to protrude though the sheath.In this condition the coil cannot be re-sheathed.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿hold the introducer sheath (loosely-looped) in the left hand.Keeping the introducer tip near the re-sheathing tool, grasp the distal end of the re-sheathing tool between your left thumb and forefinger.Grasp the clear tab near the end of the introducer sheath body with the thumb and forefinger of your other hand.Gently pull the clear tab of the introducer sheath out and away from the re sheathing tool at a 45-degree angle to unlock the microcoil.Continue to pull the tab until an additional 0.5 to 1.0 inches (1.3 to 2.5 cm) of the translucent material is exposed.Gently fold the translucent tab towards the distal end, and firmly grasp the distal end of the re sheathing tool and the translucent tab between your thumb and forefinger, as shown in figure 3¿¿ caution: if unusual friction is noticed during advancement or retraction of the microcoil system, verify the locking mechanism, or clear tab is unlocked and pulled out from the re-sheathing tool approximately 1in.(2-3cm).Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.This is 1 of 2 mdr reports being submitted for this complaint, with associated report numbers of 2954740-2017-00098 and 2954740-2017-00097.
Event or Problem Description
As reported by a healthcare professional, an envoy da catheter (67125805d/ e11363) was kinked when it was first opened, a deltapaq introducer (cdf10051030/ c38958) failed to re-zip during re-sheathing and was found to be stretched during product analysis, and there was resistance during advancement of a presidio coil (pc410073030/ c37141) through the unspecified microcatheter and the device was returned with the coil prematurely detached.The physician did not like the shape of coil deployment and decided to pull it out, but during re-sheathing the coil introducer failed to re-zip.The procedure was successfully completed with same/like products.There were no potential adverse events.After multiple attempts to obtain additional information, no information was provided.

• Brand Name: DELTAPAQ - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6556765
• Report Number: 2954740-2017-00098
• Device Sequence Number: 1010332
• Product Code: HCG
• UDI-Device Identifier: 00878528007296
• UDI-Public: (01)00878528007296(17)201031(10)C38958
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• PMA/510(K) Number: K080437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: CDF10051030
• Device Lot Number: C38958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 05/10/2017
• Patient Sequence Number: 1