MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT

Catalog Number MC1816

Device Problems Bent (1059); Break (1069); Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation of the reported event 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 stereotactic prostate biopsy in normal density tissue, after nine sample passes the device allegedly bent.It was further reported that the procedure was completed with another device and a coaxial was used.There was no reported patient injury.

Manufacturer Narrative

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 biopsy needle was returned for evaluation and four electronic photos were provided for review.Based on both the visual inspection of the returned device and the photo review, the investigation is confirmed for break, dull and bent sample notch.A break was identified at the cannula tip, the stylet tip was noted to be dull and the sample notch was found to be bent forward.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Photo review: four electronic photos were received and reviewed.The first photo shows a maxcore biopsy needle tip on a wood surface.The sample notch is not exposed, indicating that the device is either in the initial or the fully-primed position.The stylet tip appears to be bent relative to the cannula, and there appears to be a break in the cannula.The second photo shows the same maxcore biopsy needle tip from the first photo but at a higher magnification on the cannula tip.The same break in the cannula can be noted.The third photo shows the same maxcore biopsy needle tip but at a higher magnification on the stylet tip.The tip appears to be dull.The fourth photo shows the same maxcore biopsy needle tip but at a higher magnification on the stylet tip.The tip appears to be dull.Based on the photo review, the investigation is confirmed for break and dull.Labeling review: the current ifu (instructions for use) states: precautions: this product 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 organ being biopsied never test the product 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 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 the needle function.Directions for use: before using, inspect the needle for damaged point, bent shaft or other imperfections that would prevent proper function.If the needle is damaged or bent, do not use.Energize (cock) instrument by pulling back on the top slide to withdraw the cannula and lock in place.Then pull back on the bottom slide to withdraw the stylet and lock in place.Remove protective needle sheath and yellow guard.Instrument is ready to fire when both slides are locked back.Verify instrument is energized (cocked).Note: do not place fingers in front of cocking slides once instrument is energized (cocked).Impeding cocking slides' movement will impact functionality.While maintaining instrument's position and the needle orientation, depress the rear actuator button, or push the side actuator forward (direction of arrow), to cause both stylet and cannula to automatically advance.Potential complications: potential complications associated with core biopsy procedures are site specific and include, but are not limited to: hematoma; hemorrhage; infection; adjacent tissue injury; pain; bleeding; hemoptysis; hemothorax; non-target tissue, organ or vessel perforation; and air embolism.

Event Description

It was reported that during a stereotactic prostate biopsy in normal density tissue, after nine sample passes the device allegedly bent.It was further reported that the procedure was completed with another device and a coaxial was used.There was no reported patient injury.

• Brand Name: BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT
• Type of Device: 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.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7143830
• MDR Text Key: 95793222
• Report Number: 2020394-2017-01800
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084478
• UDI-Public: (01)00801741084478
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: MC1816
• Device Lot Number: REBT0383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• 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