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

Model Number MQ1410

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

A voluntary recall has been initiated for the bard® marquee® disposable core biopsy instruments and instrument kits which was product catalog/lot number specific.Reportedly the penetration depth switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.The penetration depth switch detachments may result in (1) prolongation of the biopsy procedures as the user obtains a replacement device, (2) undershooting the lesion unsuspectedly, compromising the sample quality and potentially leading to a misdiagnosis (3) or if the penetration is overshot, the device may pierce adjacent tissue and/or organs causing injury.To date, there have been no reported patient injuries associated with these penetration depth switch detachments.As a result of the field action, this event is being reported as a malfunction reportable event.The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.(expiry date: 05/2023).

Event Description

It was reported that prior to a biopsy procedure, the device button allegedly fell off.There was no patient contact.

Manufacturer Narrative

H10: a voluntary recall has been initiated for the bard® marquee® disposable core biopsy instruments and instrument kits which was product catalog/lot number specific.Reportedly the penetration depth switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.The penetration depth switch detachments may result in (1) prolongation of the biopsy procedures as the user obtains a replacement device, (2) undershooting the lesion unexpectedly, compromising the sample quality and potentially leading to a misdiagnosis (3) or if the penetration is overshot, the device may pierce adjacent tissue and/or organs causing injury.To date, there have been no reported patient injuries associated with these penetration depth switch detachments.As a result of the field action, this event is being reported as a malfunction reportable event.H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found within the device history record review to indicate there was a manufacturing related cause for this event.However, gaps within the quality control documents were identified in conjunction with the manufacturing review and will be addressed.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.The investigation is confirmed for the reported break, as the external investigation concluded that the root cause is manufacturing related, as a fixture that assembles this part was missing a pin on one side.This resulted in a gap between the knob and the depth plate/housing that resulted in the reported issue.An external investigation concluded that the root cause is manufacturing related, as a fixture that assembles this part was missing a pin on one side.This resulted in a gap between the knob and the depth plate/housing that resulted in the reported issue.Based upon the available information a definitive root cause could not be determined.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 05/2023), g3.H11: h6 (result and 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.

Event Description

It was reported that prior to an ultrasound guided breast biopsy through normal density tissue, the device button allegedly fell off.The procedure was completed using the same device.There was no patient contact.

Manufacturer Narrative

H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.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.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.An external investigation concluded that the root cause is manufacturing related, as a fixture that assembles this part was missing a pin on one side.This resulted in a gap between the knob and the depth plate/housing that resulted in the reported issue.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 05/2023).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.H3 other text : device not returned.

Event Description

It was reported that prior to an ultrasound guided breast biopsy through normal density tissue, the device button allegedly fell off.A coaxial was not used.The procedure was completed using the same device.There was no patient contact.

• Brand Name: MARQUEE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11490782
• MDR Text Key: 240044497
• Report Number: 2020394-2021-00567
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741097133
• UDI-Public: (01)00801741097133
• Combination Product (y/n): N
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MQ1410
• Device Catalogue Number: MQ1410
• Device Lot Number: 0001364078
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: UNKNOWN
• Patient Sequence Number: 1
• Patient Outcome(s): Other