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

Catalog Number	1816MSK
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2026) h11: section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that during a liver biopsy procedure, the coaxial needle allegedly bent when the patient sat up.It was further reported that the patient allegedly experienced pneumothorax which was resolved using pneumothorax kit.Reportedly, the needle was removed using forceps.The current status of the patient is unknown.
Event or Problem Description
It was reported that during a liver biopsy procedure, the coaxial needle allegedly bent when the patient sat up.It was further reported that the patient allegedly experienced pneumothorax which was resolved using pneumothorax kit.Reportedly, the needle was removed using forceps.The current status of the patient is unknown.
Additional Manufacturer Narrative
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 mission biopsy compatible coaxial in two segments and one trocar stylet were received for evaluation.During visual evaluation, a complete circumferential break was noted to the compatible coaxial cannula.The distal piece of the cannula was returned, and it was noted to be severely bent.Therefore, the investigation is confirmed for the reported bent as the coaxial cannula was noted to be bent and the investigation is confirmed for the identified break as the coaxial cannula was noted to be broken.A definitive root cause for the alleged needle bent issue and identified break issue was determined to be a procedural issue as the information provided by the complainant stated, "it was not the needle but due to the patient sitting up exactly the time the biopsy was taken".Labeling review: a review of the mission disposable core biopsy instrument instructions for use determined the product labeling documentation is adequate.Per the mission disposable core biopsy instrument instructions for use directions for use section are as follows; 1.Prepare site as required.Adequate anesthesia should be administered prior to incision of the skin.2.For ease of insertion, puncture the skin with a scalpel at the entry site.3.Verify the instrument is energized (cocked) by looking at the penetration depth indicator and confirming either a ¿10¿ or ¿20¿ is visible.4.With the inner stylet fully retracted, so that the sample notch is covered by the cannula, insert tip of needle to the point to be biopsied.Do not advance the inner stylet by pressing on the plunger until the instrument is in position.5.Press the plunger to advance the inner stylet (i.E., sample notch) into tissue.At the end of the advancement, the plunger will encounter a stop and the fire ready indicator will meet the device housing.See figure 4.With imaging, verify the sample notch is in the target area to be biopsied.6.Fire the cutting cannula by depressing the plunger past the fire ready indicator to capture the biopsy specimen in the sample notch.Note: unusual force applied to the stylet or unusual resistance against the stylet while extended out of the cannula may cause the stylet to bend at the specimen notch.A bent specimen notch may interfere with needle function.H10: d4 (expiration date: 12/2026), g3, h6 (device, method).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: MISSION KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CAREFUSION D.R. 203 LTD.; zona franca las americas; km 22-e-1; santo domingo 11606 ; DR 11606
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19708814
• Report Number: 2020394-2024-01004
• Device Sequence Number: 14225506
• Product Code: KNW
• UDI-Device Identifier: 00801741097065
• UDI-Public: (01)00801741097065
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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: 1816MSK
• Device Lot Number: 0001551186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male