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

Model Number	121616
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(expiry date: 10/2022).
Event or Problem Description
It was reported that during an ultrasound guided kidney biopsy through normal density tissue, the needle of the device allegedly stuck on tissue and failed to obtain samples.There was no reported patient injury.
Event or Problem Description
It was reported that during an ultrasound guided kidney biopsy through normal density tissue, the needle of the device allegedly stuck on tissue and failed to obtain samples.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one monopty disposable core biopsy instrument was returned for evaluation.During visual evaluation, the sample appeared clean and the device was returned in initial position, as the arrow could not be seen in the ready window.Upon functional testing, the device was able to be fully primed with no issues and the arrow was visible in the ready window.The device was functionally tested by cocking and firing the device 20 times into an apple for a total of 20 tests.The device was able to prime and fire properly.All samples were obtained with no issues.Therefore, the investigation is unconfirmed for the reported failure to obtain samples, as the device was able to obtain samples with no issues.A definitive root cause could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 10/2022), g3, h6(method).H11: section a through f: the information provide by bd represents all 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 bd.

• Brand Name: MONOPTY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11831020
• Report Number: 2020394-2021-01049
• Device Sequence Number: 14400164
• Product Code: KNW
• UDI-Device Identifier: 00801741084614
• UDI-Public: (01)00801741084614
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133948
• 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,Followup
• Report Date (Section B): 06/17/2021

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: 121616
• Device Catalogue Number: 121616
• Device Lot Number: REDY3105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other