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

Model Number VC14138MRS

Device Problems Accessory Incompatible (1004); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the accessory incompatible and detachment of device or device component could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 01/2022) device not returned.

Event Description

It was reported that during a breast biopsy procedure, the distance ring on the introducer was connected and the introducer allegedly could not be moved even after moisturizing it.It was further reported that the connection was so firm that the white plastic part was stripped off and could not be used.There was no reported patient injury.

• Brand Name: VACORA
• 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 -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12702163
• MDR Text Key: 278538565
• Report Number: 2020394-2021-01911
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741079658
• UDI-Public: (01)00801741079658
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K082681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VC14138MRS
• Device Catalogue Number: VC14138MRS
• Device Lot Number: HUDN1541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• 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