ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

Report

Report Number: 2134265-2011-00454
Event Type: Malfunction
Date Received: February 9, 2011
Date of Event: December 15, 2010
Report Date: February 9, 2011
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA
Product Code: MCX
PMA / PMN Number: P900056
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE VISUAL AND TACTILE INSPECTION REVEALED A FRACTURE AT APPROXIMATELY 316CM FROM THE PROXIMAL END AND THE SPRING TIP IS MISSING. THE OUTER DIAMETER OF THE DEVICE WAS MEASURED AND ALL MEASUREMENTS ARE WITHIN SPECIFICATIONS. THE FRACTURED SECTION WAS SENT TO THE SEM LAB AND THEIR ANALYSIS CONCLUDED THAT THE FRACTURE OCCURRED DUE TO A REDUCTION IN THE CROSS-SECTIONAL AREA OF THE WIRE DUE TO A BENDING OVERLOAD. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

SAME CASE AS: 2134265-2011-00181 AND 2134265-2011-00289. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 95% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX (CX) ARTERY. THE PHYSICIAN ADVANCED THE 325CM ROTAWIRE GUIDE WIRE AND THE 1.5MM ROTALINK BURR TO THE LESION AND BEGAN ABLATION. TWO ABLATION PASSES WERE COMPLETED WHEN THE ROTAWIRE FRACTURED. NO GUIDE WIRE FRAGMENT WAS LEFT IN THE PATIENT AND NO INTERVENTION WAS REQUIRED. THE PHYSICIAN THEN ADVANCED ANOTHER 325CM ROTAWIRE TO THE LESION AND DURING THE FOURTH ABLATION PASS THE BURR CAME INTO CONTACT WITH THE ROTAWIRE AND THE RADIOPAQUE PORTION OF THE TIP BROKE FROM THE WIRE. THE PHYSICIAN MADE A DECISION NOT TO RETRIEVE THE WIRE FRAGMENT AND THE FRAGMENT WAS LEFT IN THE DISTAL CX ARTERY. THE PROCEDURE WAS COMPLETED WITH A 3.5MM NON-BSC BALLOON AND THE DEPLOYMENT OF A 3.25MM NON-BSC STENT. THE WIRE FRAGMENT WAS NOT STENTED TO THE WALL OF THE VESSEL. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

Description of Event or Problem · 1

SAME CASE AS: 2134265-2011-00181 AND 2134265-2011-00289. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 95% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX (CX) ARTERY. THE PHYSICIAN ADVANCED THE 325CM ROTAWIRE GUIDE WIRE AND THE 1.5MM ROTALINK BURR TO THE LESION AND BEGAN ABLATION. TWO ABLATION PASSES WERE COMPLETED WHEN THE ROTAWIRE FRACTURED. NO GUIDE WIRE FRAGMENT WAS LEFT IN THE PATIENT AND NO INTERVENTION WAS REQUIRED. THE PHYSICIAN THEN ADVANCED ANOTHER 325CM ROTAWIRE TO THE LESION AND DURING THE FOURTH ABLATION PASS THE BURR CAME INTO CONTACT WITH THE ROTAWIRE AND THE RADIOPAQUE PORTION OF THE TIP BROKE FROM THE WIRE. THE PHYSICIAN MADE A DECISION NOT TO RETRIEVE THE WIRE FRAGMENT AND THE FRAGMENT WAS LEFT IN THE DISTAL CX ARTERY. THE PROCEDURE WAS COMPLETED WITH A 3.5MM NON-BSC BALLOON AND THE DEPLOYMENT OF A 3.25MM NON-BSC STENT. THE WIRE FRAGMENT WAS NOT STENTED TO THE WALL OF THE VESSEL. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR			ROTALINK BURR, 1.5MM