MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR FIRE FORWARD ACCESSORY

Catalog Number ENCFF02

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

After further clinical review of this event with bard's medical department, this event was reassessed and determined to be mdr reportable as a malfunction pursuant to 21cfr part 803.A manufacturing review was conducted and the reported lot met all release criteria.This was the first complaint to date for this lot number and failure mode.One encor fire forward was returned for evaluation.Upon receipt, there were no visual defects.The device was disassembled for an internal inspection.The complaint investigation is inconclusive as the firing distance was not measured prior to disassembly.It is unknown what the exact firing distance was during the reported event.Based on the available information, the definitive root cause is unknown.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the device is firing past the 0 position and will advance the biopsy probe approximately.8-1.4mm further than intended.There has been no reported patient injury.

• Brand Name: ENCOR FIRE FORWARD ACCESSORY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): SENORX, INC. (BPV); 1625 w. 3rd street; tempe AZ 85281
• Manufacturer Contact: christina hayes ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 5007201
• MDR Text Key: 23549243
• Report Number: 2020394-2015-01235
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCFF02
• Device Lot Number: M08040115
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/26/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1