MAUDE Adverse Event Report: CAREFUSION ACHIEVE NEEDLE BIOP SO TIS 20GX11CM COAX; GUIDE, NEEDLE, SURGICAL

Model Number CA2011

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

Reported via medwatch mw5037330: tip of biopsy gun broke off inside patient's lung.No harm to patient.No intervention required.

Manufacturer Narrative

(b)(4).Upon carefusion's investigation, a follow up medwatch will be submitted.

Manufacturer Narrative

(b)(4): if further information becomes available a follow up medwatch will be submitted.

Event Description

Additional information received on 07nov2014: the component broke during the firing of the gun for tissue collection.The mass being biopsied was at the chest wall-possibly hit rib margins.The tissue being biopsied could possibly have been harder or more rigid than the clinician intended.The tip of the tissue collector broke.The user was experienced.No injury to the patient, it was in the tissue outside the lung, no damage.There are no known current problems regarding the patient's status.

Manufacturer Narrative

(b)(4): failure mode could not be confirmed since samples were not received for evaluation.A review of the internal manufacturing device record for the reported lot number was performed and it was confirmed that procedural and functional requirements needed for its release were met.No issues were found that could relate equipment/machine to the reported failure mode.Most probable cause could not be determined since no issues were found during applicable manufacturing and packaging processes that can relate personnel or method with the reported failure and since sample was not received for material evaluation.

• Brand Name: ACHIEVE NEEDLE BIOP SO TIS 20GX11CM COAX
• Type of Device: GUIDE, NEEDLE, SURGICAL
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 203 LTD; zona franca las americas; km 22 e-1; santo domingo ; DR
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4193979
• MDR Text Key: 5150319
• Report Number: 9680904-2014-00042
• Device Sequence Number: 1
• Product Code: GDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CA2011
• Device Lot Number: 0000645604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1