MAUDE Adverse Event Report: ARGON MEDICAL DEVICES JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 7F X 50CM MAXI-CURVED

Model Number	190081
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Tachycardia (2095); Insufficient Information (4580)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is not available for return.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
"on my last pass for biopsies under echo guidance the bioptome got stuck in presumably the rv, and i was unable to pull it back without significant resistance and could not open the jaws or maneuver it much.The patient went into an svt and felt very uncomfortable.Due to her arrhythmia and discomfort, i pulled the bioptome with significant tension noted at the time and retrieved a fairly large piece of tissue on the end though the jaws remained shut and i could not release the tissue piece.That is still attached to the bioptome and the device was collected to send to the manufacturer.The patient immediately flipped out of her svt rhythm, felt better and remained hemodynamically stable".
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.Ifu under precautions- "the forcep should be thoroughly rinsed with heparinized saline prior to each specimen collection during the procedure." one opened device was returned for evaluation.The device would not actuate when received and actuating wire was bent in the handle.Distal end of device was soaked for fifteen minutes in alcohol and removed.Device would then slightly start to open upon actuation.Jaw was manipulated open and then the device was soaked again and periodically actuated.After final removal from alcohol soak, the device would actuate.Root cause of the device not working properly is most likely a foreign substance(organic) caught in the clevis area mechanism of the distal tip(jawz).A result of the device not being thoroughly rinsed.Since this issue was believed to be caused by the user not thoroughly rinsing with heparinized saline, no corrective action is necessary.The ifu has been recently updated to further stress the importance of cleaning the device upon removal.
Event or Problem Description
"on my last pass for biopsies under echo guidance the bioptome got stuck in presumably the rv, and i was unable to pull it back without significant resistance and could not open the jaws or maneuver it much.The patient went into an svt and felt very uncomfortable.Due to her arrhythmia and discomfort, i pulled the bioptome with significant tension noted at the time and retrieved a fairly large piece of tissue on the end though the jaws remained shut and i could not release the tissue piece.That is still attached to the bioptome and the device was collected to send to the manufacturer.The patient immediately flipped out of her svt rhythm, felt better and remained hemodynamically stable".
Additional Manufacturer Narrative
Sample is indicated as returned.As of the date of this report, sample has not been evaluated.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
"on my last pass for biopsies under echo guidance the bioptome got stuck in presumably the rv, and i was unable to pull it back without significant resistance and could not open the jaws or maneuver it much.The patient went into an svt and felt very uncomfortable.Due to her arrhythmia and discomfort, i pulled the bioptome with significant tension noted at the time and retrieved a fairly large piece of tissue on the end though the jaws remained shut and i could not release the tissue piece.That is still attached to the bioptome and the device was collected to send to the manufacturer.The patient immediately flipped out of her svt rhythm, felt better and remained hemodynamically stable.".

• Brand Name: JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 7F X 50CM MAXI-CURVED
• Common Device Name: JAWZ ENDOMYOCARDIAL BIOPSY FORCEP
• 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: 17021210
• Report Number: 0001625425-2023-01068
• Device Sequence Number: 6872771
• Product Code: DWZ
• UDI-Device Identifier: 00886333206827
• UDI-Public: 00886333206827
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K951447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: 190081
• Device Catalogue Number: 190081
• Device Lot Number: 5451408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 05/17/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/22/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown