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

Catalog Number ECP0110GV

Device Problems Bent (1059); Difficult to Remove (1528); Sticking (1597)

Patient Problem Pain (1994)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer 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 after a successful stereotactic biopsy procedure the patient allegedly had pain, the probe was allegedly stuck within the breast and extra force was required to remove it from the patient.Reportedly, the user noticed the needle was bent upon removal from the patient.There was no reported impact or consequence to the patient.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Visual/microscopic inspection: the aperture was 90% opened.The probe vacuum tubing was cut from the probe and not returned.No damage was identified to the rear housing.A marker applicator was returned inserted fully through the back of the probe.The grey port cap was not returned.The marker applicator was removed and one pad was seen undeployed within the applicator.The entire distal end of the probe aperture was noted to be severely twisted starting at the tip of the cutter.The aperture was examined under magnification and it was noted that the cutter had gouged into the side of the aperture; this indicated that the cutter was responsible for the twisted distal tip.The damage to the cutter was consistent with the damage to the cannula.No other anomalies were noted.The probe was examined via x-ray imaging prior to functional testing.The image shows both of the front stops to be intact on the front housing.Functional/performance evaluation: functional testing was not performed due to the poor sample condition.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: two returned electronic photos were reviewed.Both photos show an out of focus view of the distal end of a probe.Both photos show the aperture to be open and bent.Based on the photo review, the investigation can be confirmed for the reported bent device.Conclusion: one probe was returned for evaluation.The investigation is confirmed for the reported bent needle, as the distal end of the cannula was found to be bent.However, the investigation is inconclusive for the reported removal difficulties, as the conditions of use could not be recreated, and because the device was not able to be tested due to the bend.The bend in the cannula was due to the cutter catching on the cannula and twisting the cannula as the cutter oscillated.However, it is unknown how the cutter caught on the cannula.It is unknown if the bent cannula contributed to the removal difficulties.The definitive root cause could not be determined based upon available information.Labeling review: the current instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.(b)(4).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.

• Brand Name: ENCOR BIOPSY PROBE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5704233
• MDR Text Key: 48014181
• Report Number: 2020394-2016-00526
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: ECP0110GV
• Device Lot Number: VT15G0345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2015
• 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