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

Catalog Number	MC1416
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Codes	Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 04/2026).H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during a echographic guided renal biopsy procedure via the tangential oblique approach, the patient allegedly developed with intra and peri-renal hematoma.It was further reported that patient was hospitalized for intra and peri-renal hematoma.Furthermore, the cannula of the device had allegedly malfunctioned.The current status of the patient is unknown.
Event or Problem Description
It was reported that during an ultrasound-guided renal biopsy procedure through normal density tissue via the tangential oblique approach, the needle allegedly did not close to take the sample.It was further reported that the patient allegedly experienced a kidney wound with an intra and peri-renal haematoma which required hospitalisation for management.Reportedly, the hematoma was treated with ice pressure.A coaxial was used and the procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 04/2026).H11: h6 (patient).H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during an ultrasound-guided renal biopsy procedure through normal density tissue via the tangential oblique approach, the needle allegedly did not close to take the sample.It was further reported that the patient allegedly experienced a kidney wound with an intra and peri-renal haematoma which required hospitalisation for management.Reportedly, the hematoma was treated with ice pressure.A coaxial was used and the procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one maxcore device received for evaluation.Upon visual evaluation, the device appeared to have blood residue throughout the cannula and received without protective tubing and no yellow guard attached to the needle.The device was received both slides in initial position.On functional testing, the device was able to be fully primed with no issues.The device was further tested by cocking and firing the device 3 times in a chicken breast with each trigger, for a total of 6 tests.The device was able to prime and fire properly.All 6 samples were obtained with no issues.Therefore, the investigation is unconfirmed for the reported failure to fire as the device was able to prime and fire properly and all 6 samples were obtained with no issues.A definitive root cause for the alleged failure to fire could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 04/2026), g3.H11: h6 (method, result, conclusion).H11: section a through f ¿ the information provided 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: MAXCORE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19369422
• Report Number: 2020394-2024-00665
• Device Sequence Number: 20710394
• Product Code: KNW
• UDI-Device Identifier: 00801741084430
• UDI-Public: (01)00801741084430
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MC1416
• Device Lot Number: REHS4676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 07/02/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/07/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown