MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VACORA VACUUM ASSISTED BIOPSY SYS; BIOPSY INSTRUMENT

Catalog Number VB10118

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: the device was not returned for evaluation; therefore, a visual inspection was not performed.Functional/performance evaluation: the device was not returned for evaluation; therefore, functional testing was not performed.Medical records review: medical records were not provided; therefore, a medical records review was not performed.Image/photo review: three electronic photos were received and.The first photo shows the product labeling referencing catalog number huax1428 and lot number vb10118.The second photo shows the proximal end of the vacora probe faced down on the clear packing tray, the silicone tubing can be seen detached from the vacuum cylinder.The other end remains attached to the vacora probe.The third photo is a higher view of the probe as compared to the second photo.No other anomalies can be noted.Conclusion: although the sample was not returned for evaluation, three electronic photos were provided for review.The investigation is confirmed, as the silicone tube can be seen detached from the vacuum cylinder.The definitive root cause could not be determined based upon available information.It was unknown whether procedural issues contributed to the event.Labeling review: the current instructions for use (ifu) states: precautions: the vacora biopsy system should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.Potential complications: potential complications are those associated with any percutaneous removal/biopsy technique for tissue sample collection.Potential complications are limited to the region surrounding the biopsy site and include hematoma, hemorrhage, infection, a non-healing wound, pain and tissue adherence to the biopsy probe while removing it from the breast.Equipment required: surgical gloves and drapes.Directions for use: depress the "multi-function" button to begin tissue sampling sequence.The sampling process proceeds automatically: a vacuum is created, the outer cannula of the probe is automatically retracted and the tissue is drawn by vacuum into the sampling chamber.The tissue is cut using both side walls of the sampling chamber and the rotating outer cannula of the probe.Remove the probe from the breast and position the sampling chamber in the sterile sample collection container (provided with the probe).Depress the "multi-function" button until the motor engages to expose the tissue in the sampling chamber.Depress the "multi-function" button a third time to close the sample chamber and initiate the "reset" cycle.The breast biopsy procedure may be repeated as needed.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 breast biopsy, the vacuum tubing allegedly detached from the syringe during a sample sequence.It was further reported that the procedure was completed with another device.There was no reported patient injury.

• Brand Name: VACORA VACUUM ASSISTED BIOPSY SYS
• 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: 6539006
• MDR Text Key: 74255374
• Report Number: 2020394-2017-00397
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741079313
• UDI-Public: (01)00801741079313(17)190928(10)HUAX1428
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K082681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Catalogue Number: VB10118
• Device Lot Number: HUAX1428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2016
• 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
• Patient Age: 50 YR
• Patient Weight: 55