SIRIUS PINTUITION LOCALIZATION SYSTEM

Report

Report Number: 3020733550-2023-00001
Event Type: Injury
Date Received: July 12, 2023
Date of Event: May 30, 2023
Report Date: July 12, 2023
Manufacturer: SIRIUS MEDICAL SYSTEMS B.V.
Product Code: PBY
PMA / PMN Number: K222643
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE PINTUITION DETECTOR WAS RETURNED TO THE MANUFACTURER AND SUBJECTED TO FUNCTIONAL TESTING USING THE PINTUITION TEST KIT. THE DEVICE FUNCTIONED AS INTENDED AND MET PERFORMANCE SPECIFICATIONS. THOROUGH INVESTIGATION OF THE EVENTS DESCRIBED IN THIS REPORT LED TO THE CONCLUSION THAT THE DEVICE FUNCTIONED ACCORDING TO ITS INTENDED USE AS DESCRIBED IN THE DEVICE LABELING AND THERE WAS NO DEVICE MALFUNCTION IDENTIFIED. THE DEVICE INSTRUCTIONS FOR USE INCLUDE NUMEROUS CAUTION STATEMENTS ALERTING THE USER TO AVOID USE OF METAL SURGICAL INSTRUMENTS SINCE THEY ARE CAPABLE OF GENERATING A FALSE POSITIVE SIGNAL. THE SPECIFIC LABELING REFERENCES ARE AS FOLLOWS: "CAUTION. FOR BEST RESULTS, CARE SHOULD BE TAKEN WHEN USING THE PINTUITION DETECTOR IN THE PROXIMITY OF FOREIGN MAGNETIC OR METALLIC OBJECTS, AS THEY MAY GENERATE CONFOUNDING SIGNALS. IF IN DOUBT, THE USER SHOULD UNDERTAKE AN IN SITU ASSESSMENT OF THE OPERATING ENVIRONMENT BEFORE USING THE INSTRUMENT." "CAUTION. CARE SHOULD BE TAKEN TO REMOVE ALL MAGNETIC DISTURBANCES FROM THE VICINITY OF THE PROBE DURING ROUTINE USE." "CAUTION. THE DETECTION RANGE MAY BE ADVERSELY AFFECTED BY METAL (SURGICAL) INSTRUMENTS VERY CLOSE TO THE TIP OF THE PROBE. IF DETECTION IS CHALLENGING, ATTEMPT TO KEEP ANY METAL INSTRUMENTS, OBJECTS, OR OTHER MAGNETIC DISTURBANCES AT LEAST 2-5 CENTIMETERS AWAY FROM THE TIP OF THE PROBE." "CONFIRM PRESENCE OF THE SEED WITHIN THE EXCISED SPECIMEN BY GENTLY HOLDING THE PROBE TIP AGAINST THE SPECIMEN AND ASSESSING THE PRESENCE OF THE SEED. CONFIRM ABSENCE OF THE SEED IN THE SURGICAL AREA BY SCANNING THE PROBE IN AND AROUND THE SURGICAL AREA TO ASSESS THE ABSENCE OF A SIGNAL. USE AN IMAGING MODALITY SUCH AS SPECIMEN X-RAY TO CONFIRM PRESENCE OF THE SEED WITHIN THE EXCISED SPECIMEN(S)." "NOTE. IF THE SIGNAL FROM THE EXCISED SPECIMEN AND/OR THE SPECIMEN X-RAY DO NOT CONFIRM PRESENCE OF THE SEED, USERS ARE INSTRUCTED TO REASSESS THE SURGICAL AREA FOR REMAINING SIGNAL TO SEARCH FOR, IDENTIFY AND REMOVE THE SEED USING AN ADDITIONAL RESECTION." THE DEVICE INSTRUCTIONS WERE REVIEWED AND DEEMED ADEQUATE; NO LABELING DEFICIENCIES WERE IDENTIFIED. THERE IS SUFFICIENT EVIDENCE TO CONCLUDE THE EVENTS WERE CAUSED BY USE ERROR WHERE THE PHYSICIAN DID NOT FOLLOW INSTRUCTIONS FOR USE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. THE DEVICE LABELING IDENTIFIES THE POSSIBILITY OF THE NEED FOR ADDITIONAL RESECTION. THIS EVENT REQUIRED SURGICAL INTERVENTION THAT WAS NOT ORIGINALLY PLANNED. THE INTERVENTION WAS REQUIRED IN ORDER TO REMOVE THE EXISTING SUTURES, REMOVE THE INTENDED LYMPH NODE, REMOVE THE PINTUITION SEED (WHICH IS NOT APPROVED AS A PERMANENT IMPLANT), AND SUTURE THE WOUND CLOSED. IT SHOULD BE NOTED THAT THIS EVENT OCCURRED OUTSIDE THE US WHERE THE PINTUITION SEED APPROVED INDICATIONS FOR USE FOR THIS REGION INCLUDES PREOPERATIVE PERCUTANEOUS IMPLANTATION INTO LYMPH NODES IN THE AXILLARY REGION. FOR TARGETED AXILLARY DISSECTIONS, IT IS NOT UNUSUAL TO REMOVE MULTIPLE LYMPH NODES. BECAUSE THE SEED WAS PLACED IN BETWEEN TWO LYMPH NODES, IT IS VERY POSSIBLE THAT IF THE SURGEON HAD LOCATED THE SEED CORRECTLY (I.E., NO BABCOCK INTERFERENCE), THEY WOULD HAVE ELECTED TO REMOVE BOTH ADJACENT NODES IN AN ABUNDANCE OF CAUTION. MANUFACTURER'S REFERENCE #: (B)(4).

Description of Event or Problem · 0

A HEALTHCARE PROFESSIONAL REPORTED THE FOLLOWING EVENT TO MHRA. "A FALSE TARGET SIGNAL WAS DETECTED FROM THE METAL INSTRUMENT USED AT THE TIME OF SURGERY (BABCOCK'S FORCEPS). NO PATIENT HARM. THE COMPANY REPRESENTATIVE WAS PRESENT IN THE OPERATING ROOM AND WITNESSED THE EVENT. PLASTIC RETRACTORS WERE USED INSTEAD ONCE THIS WAS OBSERVED TO COMPLETE THE SURGERY." THE FOLLOWING EVENT DESCRIPTION SUMMARIZE THE MANUFACTURER'S INVESTIGATION FINDINGS OF THE SURGICAL DETAILS. THIS WAS THE SURGEON'S FIRST TIME USING THE SIRIUS PINTUITION DETECTOR AND PINTUITION SEED. SURGEON TRAINING HAD BEEN PROVIDED BY SIRIUS MEDICAL TO THE OTHER SURGEONS IN THE HOSPITAL'S TEAM, BUT THIS SURGEON REFUSED THE TRAINING OFFER. THE PINTUITION SEED HAD BEEN IMPLANTED BY THE RADIOLOGIST; THE SEED WAS INTENTIONALLY PLACED BETWEEN 2 AXILLARY LYMPH NODES TO IDENTIFY THE TARGET LYMPH NODE. ON (B)(6) 2023, THE PATIENT UNDERWENT AXILLARY LYMPHADENECTOMY USING THE PINTUITION DETECTOR TO IDENTIFY THE PINTUITION SEED, WHICH IS MAGNETIC. THE PHYSICIAN BEGAN RESECTING THE LYMPH NODE AND REPORTED THAT THE SEED HAD BEEN FOUND, THEN PROCEEDED TO CLAMP METAL BABCOCK FORCEPS ONTO THE NODE AND STARTED RESECTING IT. ONCE PARTIALLY THROUGH RESECTING, THE PHYSICIAN PLACED THE PINTUITION PROBE ON THE BABCOCK FORCEPS AND GOT TARGETLOC. AT THIS POINT, THE COMPANY REPRESENTATIVE PRESENT WARNED THE SURGEON THAT THE SYSTEM MAY HAVE LOCKED ON THE METAL INSTRUMENT AND GENERATED A FALSE POSITIVE SIGNAL, BUT THE SURGEON RESPONDED THAT THE SEED WAS IN THE BABCOCK FORCEPS, SO THE REPRESENTATIVE ASSUMED THE SURGEON HAD VISUALLY SEEN THE SEED IN THE TISSUE. THE SPECIMEN WAS RESECTED AND REMOVED FROM THE PATIENT WITH THE BABCOCK FORCEPS STILL ON IT. THE SPECIMEN WAS THEN SCANNED STILL WITHIN THE BABCOCK AND AGAIN GENERATED TARGETLOC. THE SPECIMEN WAS NOT SCANNED WITHOUT THE BABCOCK BEFORE IT WAS SENT FOR X-RAY. THE SURGEON "VERIFIED" THE PRESENCE OF THE SEED IN THE EXTRACTED SPECIMEN WHILE HOLDING THE SPECIMEN WITH BABCOCK FORCEPS WHICH IS METALLIC AND (IN RETROSPECT) CAUSED MAGNETIC DISTURBANCE. THE PHYSICIAN DID NOT CONFIRM THE ABSENCE OF THE MAGNETIC SEED IN THE SURGICAL AREA BY SCANNING THE PINTUITION PROBE IN AND AROUND THE SURGICAL AREA TO ASSESS THE ABSENCE OF A SIGNAL AS INDICATED IN THE DEVICE INSTRUCTIONS FOR USE. IN ADDITION, THE SURGEON DID NOT AWAIT CONFIRMATION FROM POSTOPERATIVE X-RAY AND ELECTED TO CLOSE THE WOUND WITH SUTURES. WHEN THE X-RAY OF THE EXCISED LYMPH NODE CAME BACK, IT DID NOT IDENTIFY THE PINTUITION SEED, INDICATING THAT THE LYMPH NODE WITH THE SEED HAD NOT BEEN REMOVED AND A DIFFERENT (ADJACENT) LYMPH NODE HAD BEEN REMOVED INSTEAD. AT THIS TIME, THE PATIENT WAS STILL ON THE OPERATING TABLE AND STILL ANESTHETIZED. THIS TIME, THE INSTRUCTIONS FOR USE WERE FOLLOWED AND CARE WAS TAKEN TO AVOID GENERATING A FALSE SIGNAL FROM METAL INSTRUMENTATION. THE PINTUITION DETECTOR IDENTIFIED THAT THE SEED WAS STILL IN THE PATIENT. THIS INDICATES THAT THE DEVICE WAS FUNCTIONING ACCORDING TO ITS INTENDED USE. THE PHYSICIAN REMOVED THE EXISTING SUTURES, REENTERED THE SAME AXILLARY INCISION, AND THE SEED WAS FOUND. THE PHYSICIAN CLARIFIED THAT THE SEED WAS NOT IN THE NODE, BUT JUST BEHIND IT. THE SURGEON SUCCESSFULLY REMOVED ANOTHER NODE AND RE-CLOSED THE WOUND WITH SUTURES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
803968	SIRIUS PINTUITION LOCALIZATION SYSTEM	IMPLANTABLE CLIP	PBY	SIRIUS MEDICAL SYSTEMS B.V.	SPBU

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention	BABCOCK FORCEPS