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

Catalog Number	DMX18041520
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr being submitted for this complaint with associated mfr# 2954740-2017-00046.Additional procode: krd.(b)(4).The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.
Event or Problem Description
As reported by a healthcare professional, during a coiling procedure a deltamaxx sr plat 18 sys 4 x 15 coil stretched.The procedure was coil embolization of an aneurysm at an unknown location.The coil had stretched during deployment.There were no damages noted on the coil prior to use.There were no adverse events however there was a time delay caused due to the reported event.It was initially reported that the complaint product is available for return.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00046.Product returned for evaluation: 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.As viewed through the returned packaging, unreported post-procedural handling produced added damage.The proximal section of the coil has been stretched.The ¿hook-like¿ designation with the arrow denotes where the stretching starts.It can also be seen at this specific location the coil was anchored.The distal section of the coil is entangled and knotted.A good portion of this damage was post-procedural in nature caused by mishandling.No manufacturing defects were found.The complaint of the coil stretching is confirmed.Due to additional and severe coil damage caused by post-procedural mishandling, cleaning, and packaging and with no further clarification of the complaint event by the end user, the exact root cause of the coil stretching cannot be determined, however the evidence as returned suggests that the most likely contributing factor to the coil stretching may have been due to the coil becoming anchored and may have led to the stretching during a retraction movement of the coil.The exact circumstances of how and when this damage occurred 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.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.Based on the information and the analysis, the event was confirmed.The exact root cause could not be determined as coil was severely damaged, however coil becoming anchored during the procedure 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.

• Brand Name: DELTAMAXX - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6383366
• Report Number: 2954740-2017-00046
• Device Sequence Number: 34364
• Product Code: HCG
• UDI-Device Identifier: 10878528001697
• UDI-Public: (01)10878528001697(17)210228(10)P11893
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/09/2017

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: 02/28/2021
• Device Catalogue Number: DMX18041520
• Device Lot Number: P11893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 03/24/2017
• Patient Sequence Number: 1