MAUDE Adverse Event Report: COVIDIEN LP BARRX SHARKCORE; KIT, NEEDLE, BIOPSY

Model Number DSC-22-01

Device Problems Difficult to Insert (1316); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the first pass was done correctly and the needle was extracted from the sheath to remove the sample, but, it was no longer possible to reinsert the needle.The needle was not folded, but, it blocked the height of the hand piece and the safety sheath dis not lock in place.The incident occurred on the first number pass and they changed the needle to correct the problem.There was no patient injury.A repeat procedure was necessary but there was no extended hospitalization or medical or surgical intervention needed.

Manufacturer Narrative

Evaluation summary: a photograph of the device was used for evaluation.The visual inspection of the customer provided photographs found needle did not engage the needle protector sheath.The reported condition was confirmed through the photographs provided.The root cause of the observed condition was determined to be a result of needle not engaging the needle protector sheath.This issue has been brought to the attention of the appropriate manufacturing personnel and a product enhancement/process improvement has been initiated/implemented to prevent this condition from recurring.A trend has been identified for this failure mode.Corrective actions have been implemented to mitigate this issue.A review of the device history records for the provided lot / serial number was completed and indicates all parameters and acceptance criteria for entries potentially pertinent to the reported event were within specified limits at the time of release.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: SHARKCORE
• Type of Device: KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 8294710
• MDR Text Key: 134882243
• Report Number: 3004904811-2019-00002
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00855208005087
• UDI-Public: 00855208005087
• Combination Product (y/n): N
• PMA/PMN Number: K141894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2020
• Device Model Number: DSC-22-01
• Device Catalogue Number: DSC-22-01
• Device Lot Number: B000000581
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1