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

Catalog Number	DFS10021020
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint met mdr reporting criteria on 1/9/2017 when the product analysis found the buckling and compression of the coil.(b)(4).Conclusion: the device was returned for analysis.The unidentified microcatheter and the rotating hemostatic valve (rhv) were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned before being returned which may have produced further damage.As viewed through the introducer sheath and outside, it was found that only the proximal end of the coil has compression and buckling, which was unreported damage.The circumstances of how and when this unreported damage occurred cannot be determined.The remainder of the coil is undamaged.The locking mechanism has compression and stretching damage.The circumstances of how and when this unreported damage occurred cannot be determined.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 device was returned for analysis.The complaint of the coil unable to be introduced and advanced into the unknown microcatheter was not confirmed.Without the identification or the return of the unknown microcatheter, the rhv, and due to unreported coil damages, the exact root cause of the introduction and advancement difficulty into the microcatheter could not be determined or tested; however, the evidence as returned highly suggests that the most likely contributing factor to the introduction and advancement difficulty of the coil may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the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.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which damaged and buckled the proximal end of the coil.This condition most likely prevented the coils introduction and advancement into the unknown microcatheter.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.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 resheathing tool approximately 1in.(2-3cm).¿ in addition, without the identification or the return of the unknown microcatheter and the rhv used in the procedure, it cannot be determined if these components had any additional contributions to the complaint event.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
During coil embolization, a deltapaq ((b)(4)) was unable to fit down the unspecified microcatheter, and during product analysis, it was found that the the proximal end of the coil had compression and buckling, which was unreported damage.They opened the same model of coil and it went down the catheter with no issues.There was no patient injury or procedure delay.

• Brand Name: DELTAPAQ - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6232283
• Report Number: 2954740-2017-00005
• Device Sequence Number: 907264
• Product Code: HCG
• UDI-Device Identifier: 00878528007616
• UDI-Public: (01)00878528007616(17)201130(10)P11487
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K080379
• 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): 11/17/2016

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: 11/30/2020
• Device Catalogue Number: DFS10021020
• Device Lot Number: P11487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 01/09/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED MICROCATHETER