MAUDE Adverse Event Report: RETRACTA DETACHABLE EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	G34200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The complainant reported that another manufacturer's catheter was positioned in the splenic artery for embolization of the splenic artery and x3 retracta detachable embolization coil had been successfully deployed.A 4th retracta detachable embolization coil was advanced through the other manufacturer's catheter and became jammed in the catheter.The physician was unable to move the retracta detachable embolization coil within the catheter, so the catheter had to be removed with the coil still inside.It was further noted that the coil was stretched approximately 10cm (centimeters) measuring approximately 5 mm (millimeters) from the proximal end of the coil.A new catheter was used to deploy more retracta and nester coils.There were no reported serious injuries to the patient as a result of the product problem.

• Brand Name: RETRACTA DETACHABLE EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• MDR Report Key: 7625072
• Report Number: 1820334-2018-01958
• Device Sequence Number: 16499967
• Product Code: KRD
• UDI-Device Identifier: 10827002342009
• UDI-Public: (01)10827002342009(17)191014(10)5323391
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: 10/14/2019
• Device Model Number: G34200
• Device Catalogue Number: MWCER-35-14-12
• Device Lot Number: 5323391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR