MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM

Model Number 360-1080-02

Device Problem Failure to Obtain Sample (2533)

Patient Problem Discomfort (2330)

Event Date 09/09/2023

Event Type  malfunction  

Event Description

I spoke to the senior charge nurse in radiology, (b)(6) who advised me that dr.(b)(6) who is a very experienced consultant, has had two issues recently when trying to use biopince.The biopince that is being returned alongside this report, is related to the incident that occurred on the (b)(6) 2023.Dr.(b)(6) was trying to take a biopsy from a lung, using c.T so is very confident he was where he needed to be but he has advised the biopince failed to retrieve a sample.As a similar thing happened just a few weeks before, he believes it is a fault with the biopince.Dr.(b)(6) has been using biopince for years and so has a lot of experience.He sent the email below with the extra detail to sister (b)(6).From: (b)(6) sent: 19 september 2023 15:07 to: (b)(6) subject: re: biopince hi (b)(6), i was the operator.Date of the more recent incident was (b)(6) 2023 procedure was a lung biopsy patient injury: the procedure was prolonged with increased discomfort to patient and risk of pneumothorax.If i had not successfully used a second gun and the patient had an inadequate biopsy they would have had a delay to potentially life saving treatment and without the biopsy a risk of not getting the correct treatment.As well as this there was the previous failure i was the operator date was (b)(6) 2023 again it was a lung biopsy similar problem and risk to patient.The other patient on that day did not have a successful biopsy and it was a tricky position so i abandoned when there was a haemoptysis , but now i wonder if it was an equipment failure too.Kind regards (b)(6) consultant radiologist, (b)(6).

Manufacturer Narrative

The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

Event Description

I spoke to the senior charge nurse in radiology, (b)(6) who advised me that dr.(b)(6) , who is a very experienced consultant, has had two issues recently when trying to use biopince.The biopince that is being returned alongside this report, is related to the incident that occurred on the on (b)(6) 2023.Dr.(b)(6) was trying to take a biopsy from a lung, using c.T so is very confident he was where he needed to be but he has advised the biopince failed to retrieve a sample.As a similar thing happened just a few weeks before, he believes it is a fault with the biopince.Dr.(b)(6) has been using biopince for years and so has a lot of experience.He sent the email below with the extra detail to sister (b)(6).From: (b)(6) sent: on (b)(6) 2023 15:07 to: (b)(6) subject: re: biopince hi (b)(6) , i was the operator.Date of the more recent incident was on (b)(6)2023 procedure was a lung biopsy patient injury: the procedure was prolonged with increased discomfort to patient and risk of pneumothorax.If i had not successfully used a second gun and the patient had an inadequate biopsy they would have had a delay to potentially life saving treatment and without the biopsy a risk of not getting the correct treatment.As well asthis there was the previous failure i was the operator date was on (b)(6)2023 again it was a lung biopsy similar problem and risk to patient.The other patient on that day did not have a successful biopsy and it was a tricky position so i abandoned when there was a haemoptysis , but now i wonder if it was an equipment failure too.Kind regards (b)(6) consultant radiologist, (b)(6) hospital (b)(6).

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.One opened sample was returned from the customer for review.A visual inspection was performed on the returned product, and it was found that the pincer was completely broken off from the device, inhibiting it from properly obtaining a sample.The complaint was confirmed.There are stringent computer and photographic inspections that ensure the pincer is not deformed during the manufacturing process and has the proper radius.When the device is cocked, the pincer comes out of its window and becomes exposed to the tissues and structures present during the operation.It is also possible that the needle set was inserted into tissue that was too hard for the sensitive pincer, pushing it flat.Additionally, once a pincer is flattened, it becomes possible to hit the window structure when firing, which results in the pincer folding up and into an arch shape.If this happens and is then pulled back, it can be pushed flat while folded and ¿pancake¿ onto itself and can finally be broken.Since the most likely cause for the damaged needles is related to an event within the user's environment and not a manufacturing issue, no corrective action can be implemented at this time.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM
• Type of Device: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 17950104
• MDR Text Key: 327027149
• Report Number: 0001625425-2023-01230
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00886333224005
• UDI-Public: 00886333224005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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
• Device Operator: Health Professional
• Device Model Number: 360-1080-02
• Device Lot Number: 11476000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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): Other