MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUGUIDE COAXIAL; DISPOSABLE BIOPSY

Catalog Number UNK TRUGUIDE

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Perforation of Vessels (2135)

Event Date 03/27/2022

Event Type  Injury  

Event Description

It was reported in the article "2022 - megale a - broken biopsy needle penetrating aorta" that the coaxial needle was broken into two parts, migrated into mediastinum cavity and it had perforated the aorta.It was further reported that the broken coaxial needle fragment was removed under fluoroscopy successfully.The current status of the patient is not provided.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Adalberto batalha megale, guilherme cayres mariotti, mario claudio ghefter, nelson hamerschlak and rodrigo gobbo garcia (2022).Broken biopsy needle penetrating the aorta.J vasc interv radiol jul; 33(7):874-875.Doi:10.1016/j.Jvir.2022.03.072.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 in the article "2022 - megale a - broken biopsy needle penetrating aorta" that the coaxial needle was broken into two parts, migrated into mediastinum cavity and it had perforated the aorta.It was further reported that the broken coaxial needle fragment was removed under fluoroscopy successfully.The current status of the patient is not provided.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical sample was not returned for evaluation.Five electronic images and one electronic photo were provided and reviewed within the article, the first computed tomography image shows the needle position into the pulmonary consolidation.Second computed tomography image shows the broken coaxial needle with migration of the fragment into the mediastinum.Third cone-beam computed tomography image shows the migration of the broken coaxial needle fragment into the mediastinum, perforating the aorta.Forth fluoroscopy image shows the surgical exploration to guide the videoscope to the needle fragment and the fifth video-assisted thoracoscopic surgery image shows the needle fragment adjacent to the mediastinal pleura, protruded from the periaortic fatty tissue.The provided photo shows the coaxial needle fragment after removal.Therefore, based on the photo review, the reported detachment issue can be confirmed.Based on the findings, the investigation is confirmed for the reported detachment issue as detached coaxial needle can be noted.A definitive root cause for the detachment issue 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.Adalberto batalha megale, guilherme cayres mariotti, mario claudio ghefter, nelson hamerschlak and rodrigo gobbo garcia (2022).Broken biopsy needle penetrating the aorta.J vasc interv radiol jul; 33(7):874-875.Doi:(b)(4).H10: g3, h6 (method).H11: h6 (device, result).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: TRUGUIDE COAXIAL
• Type of Device: DISPOSABLE BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15173064
• MDR Text Key: 297313758
• Report Number: 2020394-2022-00635
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K936194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK TRUGUIDE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male