MAUDE Adverse Event Report: ARTHROCARE CORP CLEAR-VIEW ACCESS NEEDLE; CANNULAE

Catalog Number KP-BPS-1502-01

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/20/2012

Event Type  malfunction  

Event Description

It was reported that during a pelvic needle biopsy procedure using a clear-view access needle, the needle broke off in the bone upon insertion.The broken piece was abandoned in the bone.No further details were provided regarding the procedure outcome, however, no further pt complications were reported as a result of this event.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.It is possible that the customer used the needle with excessive force.The ifu warns "excessive force may cause damage to the access needle.Care should be taken during access needle insertion especially in dense, hard bone.A needle stylet (either beveled, self-tapping, or diamond point) must be in place within the needle cannula whenever inserting or redirecting the needle during insertion." there are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: CLEAR-VIEW ACCESS NEEDLE
• Type of Device: CANNULAE
• Manufacturer (Section D): ARTHROCARE CORP; austin TX
• Manufacturer (Section G): ARTHROCARE COSTA RICA; la aurora, heredia ; CS
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr; bldg 1; austin, TX 78735 ; 5123585933
• MDR Report Key: 4315041
• MDR Text Key: 5254476
• Report Number: 3006524618-2014-00333
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Catalogue Number: KP-BPS-1502-01
• Device Lot Number: M206649
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 11/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other