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

Model Number 1816MSK

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The return of the device is pending.The investigation is currently underway.The information provided by bard 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 bard.

Event Description

It was reported that during a biopsy, while the doctor was attempting to reposition the coaxial inside the patient, the coaxial allegedly broke.It was further reported that the inner needle of the coaxial bent.Reportedly, the coaxial and inner needle were removed and biopsy was completed.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not returned and no electronic photos were provided.Therefore, the investigation is inconclusive for break and bent as the sample was not available for evaluation and no objective evidence was provided for review.Per the reported event details, the coaxial was placed in the target tissue and an attempt to reposition was performed.While a definitive root cause could not be determined based upon available information, procedural issues may have contributed to the reported event.Labeling review: the current ifu (instructions for use) states: indications for use: -the bard® mission® disposable core biopsy instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.It is not intended for use in bone.-the bard® truguide® disposable coaxial biopsy needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.Warnings: -post-biopsy patient care may vary with the biopsy technique utilized and the individual patient¿s physiological condition.Observation of vital signs and other precautions should be taken to avoid and/or treat potential complications that may be associated with biopsy procedures.-note: inspect the bard® mission® disposable core biopsy instrument and bard® truguide® disposable coaxial biopsy needle for damaged point, bent shaft or other imperfections prior to use and after each sample is collected.Do not use the device if any imperfection is noted.Precautions: -the bard® mission® disposable core biopsy instrument and bard® truguide® disposable coaxial biopsy needle should be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of core needle biopsy, in particular, those relating to the specific tissue being biopsied.-the introduction of the needle into the body should be carried out under imaging guidance (ultrasound, x-ray, ct etc.).Note: this product has not been tested for mr imaging compatibility.-never test the bard® mission® disposable core biopsy instrument by firing into the air.Damage may occur to the needle/cannula tip and could result in patient and/or user injury.-unusual force applied to the bard® mission® disposable core biopsy instrument stylet or unusual resistance against the stylet while extended out of the supportive cannula may cause the stylet to bend at the specimen notch.A bent specimen notch may interfere with needle function.

Event Description

It was reported that during a biopsy, while the doctor was attempting to reposition the coaxial inside the patient, the coaxial allegedly broke.It was further reported that the inner needle of the coaxial bent.Reportedly, the coaxial and inner needle were removed and biopsy was completed.There was no reported patient injury.

• Brand Name: BARD MISSION DISPOSABLE CORE BIOPSY INSTRUMENT KIT
• 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; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7277229
• MDR Text Key: 100471483
• Report Number: 2020394-2018-00121
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741097065
• UDI-Public: (01)00801741097065
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K171953
• 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,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1816MSK
• Device Catalogue Number: 1816MSK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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