MICRUSFRAME18 14MM X 47CM

Report

Report Number: 3008114965-2018-00791
Event Type: Malfunction
Date Received: November 20, 2018
Date of Event: November 7, 2018
Report Date: November 7, 2018
Manufacturer: SEE H.10
Product Code: KRD
UDI-DI: 10886704078111
PMA / PMN Number: K150319
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

(B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF THE PULMONARY ARTERIOVENOUS MALFORMATION (AVF) AT THE PULMONARY VEIN, THE MICROCATHETER (LIGHTHOUSE, PIOLAX) WAS INSERTED AND THE MICRUSFRAME 18 14MM X 47CM COIL (B)(4) WAS INSERTED INTO THE MICROCATHETER WHERE IT BECAME IMPEDED. IT WAS CONFIRMED THAT THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER DURING THE ACCESSING OF THE TARGET SITE. THE RESISTANCE WAS BETWEEN THE MICRUSFRAME 18 COIL AND THE MICROCATHETER. THE COIL WAS REMOVED, AND IT UNRAVELED. THE MICRUSFRAME 18 COIL AND THE MICROCATHETER WERE REMOVED AND REPLACED. A PROGREAT® (TERUMO) MICROCATHETER WAS USED WITH A NEW MICRUSFRAME 18 COIL AND THE COIL WAS SUCCESSFULLY PLACED AT THE TARGET SITE WITHOUT ANY PATIENT CONSEQUENCE. IT WAS REPORTED THAT SUSTAINED, ADEQUATE FLUSH WAS MAINTAINED. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT HAS BEEN RETURNED AND WAS EVALUATED. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. THE COMPLAINT PRODUCT WAS RETURNED INSIDE THE CONCOMITANT CATHETER (LIGHTHOUSE, PIOLAX). NO DEVICE POSITIONING UNIT (DPU) WAS SEEN, BUT THE DISTAL END OF THE EMBOLIC COIL WAS EXPOSED FROM THE DISTAL END OF THE MICROCATHETER. THE DISTAL END OF THE EMBOLIC COIL SEEN ADVANCED THROUGH THE MICROCATHETER. NO PART OF THE COMPLAINT DEVICE WAS SEEN AT THE PROXIMAL END OF THE MICROCATHETER. A SLIGHT BEND WAS SEEN ON THE CONCOMITANT MICROCATHETER AT 24 CM FROM ITS PROXIMAL END. MORE BENDS WERE SEEN ON THE CONCOMITANT MICROCATHETER AT 74 AND 89 CM FROM ITS PROXIMAL END. THE EMBOLIC COIL WAS THEN PULLED OUT FROM THE DISTAL END OF THE MICROCATHETER. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. BLOOD WAS SEEN ON THE EMBOLIC COIL. THE DISTAL END OF THE MICROCATHETER WITH THE EMBOLIC COIL STILL INSIDE. THE PROXIMAL END OF THE EMBOLIC COIL WAS SEEN COVERED IN BLOOD. NO KINKS OR DAMAGE WAS SEEN THROUGHOUT THE COIL LENGTH. A GUIDEWIRE WAS ATTEMPTED TO PASS THROUGH THE CONCOMITANT MICROCATHETER AFTER THE COIL WAS REMOVED, AND WAS SUCCESSFULLY ADVANCED, HOWEVER A SIGNIFICANT AMOUNT OF DRIED BLOOD HAD BEEN PUSHED FROM INSIDE THE MICROCATHETER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L11607) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE REPORTED ISSUE IN THE COMPLAINT THAT THE 14 MM X 47 CM MICRUSFRAME 18 COIL BECAME IMPEDED IN THE MICROCATHETER AND THE COIL BECAME UNRAVELED WHEN IT WAS REMOVED WAS NOT CONFIRMED DURING THE ANALYSIS OF THE RETURNED DEVICE. THE SLIGHT BEND NOTED ON THE CONCOMITANT MICROCATHETER AT 24 CM FROM ITS PROXIMAL END AND THE BENDS AT 74 AND 89 CM FROM THE PROXIMAL END MIGHT HAVE RESULTED IN THE REPORTED ISSUE. THE EMBOLIC COIL WAS INSPECTED UNDER A MICROSCOPE. THE BALL TIP WAS PRESENT AND INTACT, THE COIL WAS NOT UNRAVELED AS REPORTED. THE EMBOLIC COIL DID NOT HAVE ANY NOTICEABLE DAMAGE SUCH AS KINKS ALONG ITS LENGTH. THE DRIED BLOOD OBSERVED ON THE EMBOLIC COIL AND ON THE CONCOMITANT MICROCATHETER SUGGESTS THAT AN INSUFFICIENT FLUSH WAS MAINTAINED. THE INSTRUCTION FOR USE (IFU) STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE. IN THE EVENT THAT RESISTANCE IS ENCOUNTERED BETWEEN THE COIL AND THE MICROCATHETER, AS WAS REPORTED IN THIS COMPLAINT, THE FLUSH SHOULD BE VERIFIED. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE/CONTRIBUTE TO RESISTANCE BETWEEN THE TWO DEVICES. THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, WITH THE OBSERVATION OF DRIED BLOOD ON THE RETURNED DEVICE AND ON THE CONCOMITANT MICROCATHETER IS AN INDICATION THAT IT MIGHT HAVE BEEN DUE TO THE ABSENT OF AN INSUFFICIENT FLUSH. THE BENDS OBSERVED ON THE CONCOMITANT MICROCATHETER ARE ALSO POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED ISSUE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

Additional Manufacturer Narrative · 0

(B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO DOCUMENT THE RESULT OF THE ANALYSIS OF THE PRODUCTION RECORDS FOR LOT L11607, AND TO REPORT THAT REPORT THAT THE PRODUCT WAS RECEIVED BY THE PRODUCT ANALYSIS LAB ON (B)(6) 2018. THE RETURN PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L11607) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 0

MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 12/20/2018. THE INITIAL REPORTER TITLE AND LAST NAME WAS ADDED. THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER ADDRESS IS: (B)(6). [ADDITIONAL INFORMATION]: THE HEALTHCARE PROFESSIONAL 66) REPORTED THAT DURING THE COIL EMBOLIZATION OF THE PULMONARY ARTERIOVENOUS MALFORMATION (AVF) AT THE PULMONARY VEIN, THE MICROCATHETER (LIGHTHOUSE, PIOLAX) WAS INSERTED AND THE MICRUSFRAME 18 14MM X 47CM COIL (MFR181447 / L11607) WAS INSERTED INTO THE MICROCATHETER WHERE IT BECAME IMPEDED. IT WAS CONFIRMED THAT THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER DURING THE ACCESSING OF THE TARGET SITE. THE RESISTANCE WAS BETWEEN THE MICRUSFRAME 18 COIL AND THE MICROCATHETER. THE COIL WAS REMOVED, AND IT UNRAVELED. THE MICRUSFRAME 18 COIL AND THE MICROCATHETER WERE REMOVED AND REPLACED. A PROGREAT® (TERUMO) MICROCATHETER WAS USED WITH A NEW MICRUSFRAME 18 COIL AND THE COIL WAS SUCCESSFULLY PLACED AT THE TARGET SITE WITHOUT ANY PATIENT CONSEQUENCE. IT WAS REPORTED THAT SUSTAINED, ADEQUATE FLUSH WAS MAINTAINED. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT HAS BEEN RETURNED AND IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. (B)(4). THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem · 1

THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF THE PULMONARY ARTERIOVENOUS MALFORMATION (AVF) AT THE PULMONARY VEIN, THE MICROCATHETER (LIGHTHOUSE, PIOLAX) WAS INSERTED AND THE MICRUSFRAME 18 14MM X 47CM COIL (MFR181447 / L11607) WAS INSERTED INTO THE MICROCATHETER WHERE IT BECAME IMPEDED. THE COIL WAS REMOVED, AND IT UNRAVELED. IT WAS REPORTED THAT SUSTAINED, ADEQUATE FLUSH WAS MAINTAINED. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
931558	MICRUSFRAME18 14MM X 47CM	NEUROVASCULAR EMBOLIZATION DEVICE	KRD	SEE H.10		L11607	10886704078111

Patients

Seq	Age	Sex	Outcome	Treatment
1				PIOLAX LIGHTHOUSE MICROCATHETER