MAUDE Adverse Event Report: VASORUM LTD. CELT ACD VASCULAR CLOSURE DEVICE

Model Number	KCLT-6F
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
Event or Problem Description
Device was deployed, no indication of malfunction.After step three (clip release) was performed, there was immediate bleeding from the puncture site.Immediate flouro after revealed the implant was in the mid sfa.Manual compression achieved hemostasis.The physician elected to retrieve the device using an embolic protection device (emboshield nav 6).They were able to capture the device using this method.When the device was pulled back to the end of the sheath, an attempt was made to pull out the sheath and the filter basket (containing the implant) as one unit.The sheath came out, but the filter basket could not be pulled out.Manual compression was applied to achieve hemostasis and the patient was transferred to a hospital for a scheduled surgical removal.

• Brand Name: CELT ACD VASCULAR CLOSURE DEVICE
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): VASORUM LTD.; 2012 orchad avenue; citywest business park; dublin, leinster D24WP W6; EI D24WPW6
• MDR Report Key: 6935337
• Report Number: 3009984513-2017-00001
• Device Sequence Number: 482990
• Product Code: MGB
• UDI-Device Identifier: 05391530280082
• UDI-Public: (01)05391530280082(17)200630(10)453955
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: KCLT-6F
• Device Lot Number: 453955
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 84