MAUDE Adverse Event Report: COVIDIEN (IRVINE) CONCERTO PGLA HLX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	PV-12-30-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, the device is pending return.Upon receipt of the device a supplemental report will be filed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during coiling treatment of distal gonadal vein, this coil would not detach with manual detachment method (breaking hypotube method; an alternative method presented in the instruction for use).The physician tried 3-4 times with manual method but still coil did not detach.It was reported that physician did not use instant detacher to detach the coil.Another coil was used and procedure completed successfully.No patient injury was reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA
• MDR Report Key: 6417666
• Report Number: 2029214-2017-00195
• Device Sequence Number: 10978118
• Product Code: KRD
• UDI-Device Identifier: 00847536016941
• UDI-Public: 00847536016941
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2017

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: 07/21/2019
• Device Model Number: PV-12-30-HELIX
• Device Lot Number: A314595
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1