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

Model Number	VC14138MRS
Medical Device Problem Codes	Accessory Incompatible (1004); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12702163
• Report Number: 2020394-2021-01911
• Device Sequence Number: 4613645
• Product Code: KNW
• UDI-Device Identifier: 00801741079658
• UDI-Public: (01)00801741079658
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VC14138MRS
• Device Catalogue Number: VC14138MRS
• Device Lot Number: HUDN1541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1