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

Catalog Number	DFS10025020
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial mdr report being submitted for this complaint with associated mfr# 2954740-2017-00003 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 procedure for treatment of epistaxis on (b)(6) 2016 the physician was unable to detach a deltapaq coil (dfs10031020/p11886) using a connecting cable 157cm (ccb00015700/s11564).The detachment was attempted again using a new cable and exact same type of coil and it worked correctly.The issue did not cause any patient harm nor did it cause any significant delay, only to realize there was an issue with the products and swapping them for a working unit.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# 2954740-2017-00003.Limited information was received.The unidentified detachment control box (dcb) was not returned.The unidentified microcatheter was 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 damage of the coil being detached was found.The coil was found protruding through the distal tip of the green introducer.Unreported damage of the device positioning unit (dpu) being completely removed from the sheath was found.Unreported damage of the coil protruding through the sheath at the distal tip of the skive and unreported stretching of the coil was found.Unreported damage of the coil being knotted at the distal tip of the green introducer was found.The coil was found to have been mechanically detached.The detachment fiber did not receive heat and melt.The device positioning unit (dpu) passed electrical testing with resistance at 52.2 ohms (range 48.5/56.0) and the test enpower and cable systems ready green light illuminated (deltapaq ifu).No manufacturing defects were found.The exact circumstances of how and when all the unreported damages found to the unit that are contained in this report occurred cannot be determined.The complaint of the coils non-detachment cannot be confirmed.The dpu passed all electrical testing; therefore the root cause of the coils non-detachment cannot be determined.In addition, without the return of the unidentified dcb (complete detachment system) used in the procedure, it cannot be determined if this component contributed to the complaint event.The evidence as received highly suggests that all the unreported damage contained in this report occurred outside the patient and was most likely post-procedural in nature.The coil knotting could have only occurred between the distal tip of the green introducer and the proximal end of the rhv which started a cascading series of events as reported above.The knotted coil during retraction became anchored on the distal tip of the green introducer.This anchoring effect most likely caused the dpu to protrude causing the coil to stretch and then have a mechanical detachment via the detachment fiber, however the exact circumstances of how and when this occurred cannot be determined, but the evidence shows that it occurred outside the patient.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 analysis, the event was not confirmed.The returned product passed testing and 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 unreported damages occurred outside the patient and were determined to be procedural in nature.Therefore, no corrective actions will be taken at this time.

• 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: 6229300
• Report Number: 2954740-2017-00003
• Device Sequence Number: 11001693
• Product Code: HCG
• UDI-Device Identifier: 00878528007661
• UDI-Public: (01)00878528007661(17)210228(10)P11886
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142429
• 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): 12/15/2016

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: 02/28/2021
• Device Catalogue Number: DFS10025020
• Device Lot Number: P11886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 01/20/2017
• Patient Sequence Number: 1