MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BIOPSY MISSION KIT; BIOPSY INSTRUMENT

Catalog Number 1816MSK

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 during a ct guided biopsy through a soft lesion below the spine, the coaxial needle allegedly broke while being manipulated and angled against bone.It was further reported that the coaxial was allegedly withdrawn bent as it was removed in one piece from the target tissue.Reportedly, the procedure was completed with another device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual/microscopic inspection: the mission needle was returned in the initial position (not primed) with the cannula at the 0mm position.The mission needle was returned with one truguide coaxial cannula and blunt tip stylet.It was noted that the coaxial cannula was broken in two portions.The break occured 1.9835" from the distal tip of the cannula.The broken end of the proximal portion of the needle was found to be bent, indicating excessive force had been applied to the cannula.Per the event details, it was noted that the coaxial was angled against bone.Functional/performance evaluation: functional/performance evaluation could not be performed due to the condition in which the sample was received.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: one mission biopsy needle, one coaxial cannula, and one blunt tip stylet were returned for evaluation.The investigation is confirmed for bend and break, as the coaxial cannula was found to be broken into two pieces and the broken end of the proximal portion of the cannula was bent.The root cause was determined to be user related.Per the reported event details, the coaxial cannula was angulated against a bone.Therefore, it was determined that anatomical and procedural factors contributed to the reported event.Labeling review: the current mission disposable biopsy instrument instructions for use (ifu)provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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 during a ct guided biopsy through a soft lesion below the spine, the coaxial needle allegedly broke while being manipulated and angled against bone.It was further reported that the coaxial was allegedly withdrawn bent as it was removed in one piece from the target tissue.Reportedly, the procedure was completed with another device.There was no reported patient injury.

• Brand Name: BIOPSY MISSION KIT
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5866923
• MDR Text Key: 51824654
• Report Number: 2020394-2016-00761
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Catalogue Number: 1816MSK
• Device Lot Number: HUAP0265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2016
• 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