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

Model Number	ECP0110G
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 06/2023).
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy through fatty density tissue, the needle was allegedly bent.It was further reported the device was allegedly difficult to remove from the patient.The procedure was completed by using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy through fatty density tissue, the needle was allegedly bent.It was further reported the device was allegedly difficult to remove from the patient.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: two electronic photos were provided for review.One photo shows the label information which was verified with tw.Another photo shows the needle of the device where the cutting portion of the needle was noted to bent upwards.Based on the photo review, the reported failure needle bent can be confirmed.However, based on the photo review , the reported difficult to remove is cannot be confirmed.Therefore, the investigation for the reported needle bent is confirmed as there were proper evident provided.However, the investigation for the reported difficult to remove is kept as inconclusive as there were no proper evident provided.One encor biopsy probe, removable probe cover and partial vacuum assembly were returned for evaluation.On visual evaluation, the probe appeared to have residue throughout and the aperture was received in a closed condition.And it was further noted that the cutter was bent outside the aperture.Due to the condition of the device and nature of the complaint functional testing was not performed.Therefore, the investigation for the reported needle bent is confirmed as the bent was noted during visual evaluation.However, the investigation for the reported difficult to remove is kept as inconclusive as the functional testing was not performed.A definitive root cause for the alleged needle bent and difficult to remove could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 06/2023), g3, h2.H11: h6(method).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 an ultrasound guided breast biopsy through fatty density tissue, the needle was allegedly bent.It was further reported the device was allegedly difficult to remove from the patient.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: the physical device was not returned for evaluation.Two electronic photos were review.One photo shows the label information which was verified with tw.Another photo shows the needle of the device where the cutting portion of the needle was noted to bent upwards.Based on the photo review, the reported failure needle bent can be confirmed.However, based on the photo review , the reported difficult to remove is cannot be confirmed.Therefore, the investigation for the reported needle bent is confirmed as there were proper evident provided.However, the investigation for the reported difficult to remove is kept as inconclusive as there were no proper evident provided.A definitive root cause for the alleged needle bent and difficult to remove could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 06/2023), g3, h6(method).H11: h6(result, conclusion).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.

• Brand Name: ENCOR PROBE
• Common Device Name: 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14913369
• Report Number: 2020394-2022-00533
• Device Sequence Number: 19304411
• Product Code: KNW
• UDI-Device Identifier: 00801741086243
• UDI-Public: (01)00801741086243
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K040842
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ECP0110G
• Device Catalogue Number: ECP0110G
• Device Lot Number: VTFRD001
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 09/02/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 08/11/2022; 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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
• Patient Sex: Female