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

Catalog Number	CDX18041530
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial mdr report being submitted for this complaint with associated mfr# 2954740-2016-00313.Additional procode: krd.(b)(4).The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.
Event or Problem Description
It was reported by a healthcare professional that during the coil embolization procedure the first coil used a deltamaxx cerecyte (cdx18041530/c38845) coil could not be advanced via the distal shaft of the microcatheter (type/lot unknown).The coil was reshaped before this issue.The coil was withdrawn still attached to the delivery system; however was found to be stretched.Only the complaint coil was removed from the patient; the reported event did not require exchange of the microcatheter and the same catheter was used with a new coil to complete the procedure.There were no kinks noted on the microcatheter or damages noted on the complaint coil prior to use.An adequate continuous flush was maintained through the microcatheter at all times.There was no report on the patient injury.There were no intra or post procedural complications or surgical delays related to device or reported event.Patient information is unknown, patient outcome was reported to be fine.It was initially reported that the complaint product is available for return.
Additional Manufacturer Narrative
This is one of one final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00313.Limited information was received.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.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location and measurement callouts are approximate and for reference only.Unreported damage of the device positioning unit (dpu) protruding out of the sheath located 23.5 centimeters off the distal tip of the green introducer was found.No mechanical sheath damage was found at the protrusion site.The circumstances of how and when the unreported damage of the dpu protruding out of the sheath cannot be determined.The coil was stretched at the proximal section.The distal section of the coil retained its secondary shaping, but has primary coiling damage with the ball tip and the stretch resistance suture being severed off the coil.The circumstances of how and when the unreported stretch resistant suture was severed cannot be determined.No manufacturing defects were found.The complaint of the coil unable to be advanced through the distal section of the unknown microcatheter is not confirmed.Without the return of the unidentified microcatheter and due to the fact that the coil was returned severely damaged which prevented laboratory testing, the root cause of the coils advancement difficulty inside the distal shaft of the microcatheter cannot be determined.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 contributed to the complaint event.The complaint of the coil being stretched is confirmed.While the exact root cause cannot be determined, the most likely contributing factor may have been due to that the coil was temporarily anchored by an unknown source and location which would have caused the coil to stretch upon removal.This anchoring effect may have also contributed to the stretch resistance suture to have been severed.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 contributed to the complaint event.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 coil¿s resistance inside the catheter could not be confirmed; the coil could not be tested as it was received severely damaged.The complaint of the coil being stretched is confirmed.Although a definitive conclusion cannot be made, based on the analysis, it appears that coil being temporarily anchored by an unknown source was the primary cause of 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.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6176558
• Report Number: 2954740-2016-00313
• Device Sequence Number: 899913
• Product Code: HCG
• UDI-Device Identifier: 10878528008559
• UDI-Public: (01)10878528008559(17)201031(10)C38845
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120274
• 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,Followup
• Report Date (Section B): 12/02/2016

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: 10/31/2020
• Device Catalogue Number: CDX18041530
• Device Lot Number: C38845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 01/10/2017
• Patient Sequence Number: 1