ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

Report

Report Number: 2134265-2013-02359
Event Type: Injury
Date Received: April 16, 2013
Date of Event: March 18, 2013
Report Date: March 18, 2013
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
Product Code: MCX
PMA / PMN Number: P900056
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

UPDATE: DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD, RESULTS AND CONCLUSION CODES. DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED THE SPRING TIP MISSING. THE OVERALL LENGTH OF THE GUIDEWIRE IS 229.2CM APPROXIMATELY. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. THE MTAC LAB RESULTS REVEALED EVIDENCE OF TORSION OVERLOAD FOLLOWED BY FINAL TENSION OVERLOAD FOR BOTH FAILURE SITES A (SURROUNDING COIL) AND B (COREWIRE). THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE ROTAWIRE GUIDE WIRE FRACTURED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ADVANCED THE 330CM FLOPPY ROTAWIRE GUIDE WIRE TO THE POSTERIOR DESCENDING ARTERY OF THE RIGHT CORONARY ARTERY. A 1.75MM ROTABLATOR ROTALINK PLUS DEVICE WAS ADVANCED OVER THE GUIDE WIRE TO THE LESION. THE GUIDE WIRE FRACTURED AT THE RADIOPAQUE PART OF THE DISTAL TIP. THEY WERE UNABLE TO RETRIEVE THE FRAGMENT AS IT WAS IN VESSEL THAT COULD NOT BE ACCESSED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF AN UNSPECIFIED STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE ROTAWIRE GUIDE WIRE FRACTURED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ADVANCED THE 330CM FLOPPY ROTAWIRE GUIDE WIRE TO THE POSTERIOR DESCENDING ARTERY OF THE RIGHT CORONARY ARTERY. A 1.75MM ROTABLATOR ROTALINK PLUS DEVICE WAS ADVANCED OVER THE GUIDE WIRE TO THE LESION. THE GUIDE WIRE FRACTURED AT THE RADIOPAQUE PART OF THE DISTAL TIP. THEY WERE UNABLE TO RETRIEVE THE FRAGMENT AS IT WAS IN VESSEL THAT COULD NOT BE ACCESSED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF AN UNSPECIFIED STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE ROTAWIRE GUIDE WIRE FRACTURED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ADVANCED THE 330CM FLOPPY ROTAWIRE GUIDE WIRE TO THE POSTERIOR DESCENDING ARTERY OF THE RIGHT CORONARY ARTERY. A 1.75MM ROTABLATOR ROTALINK PLUS DEVICE WAS ADVANCED OVER THE GUIDE WIRE TO THE LESION. THE GUIDE WIRE FRACTURED AT THE RADIOPAQUE PART OF THE DISTAL TIP. THEY WERE UNABLE TO RETRIEVE THE FRAGMENT AS IT WAS IN VESSEL THAT COULD NOT BE ACCESSED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF AN UNSPECIFIED STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
161915	ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM	CATHETER, CORONARY, ATHERECTOMY	MCX	BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)	H802228240020	15626689

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention