ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

Report

Report Number: 2134265-2013-04291
Event Type: Injury
Date Received: June 20, 2013
Date of Event: May 22, 2013
Report Date: May 23, 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

(B)(4).

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND TACTILE INSPECTION WAS PERFORMED WHICH IDENTIFIED THE DEVICE WAS RETURNED FRACTURED IN TWO SECTIONS. THE PROXIMAL SECTION PRESENTED THE BODY KINKED AT 251.0CM, 225.5CM AND AT 228.3CM FROM THE PROXIMAL END. ALL THE OUTER DIAMETER MEASUREMENTS TAKEN ARE WITHIN SPECIFICATION. THE RETURNED DEVICE WAS SENT FOR EXTERNAL ANALYSIS ((B)(4) LAB) TO DETERMINE THE FRACTURE FAILURE MODE. RESULTS CONFIRMED THE FAILURE ON BOTH SAMPLES OCCURRED DUE TO A ROTATIONAL WEAR REDUCTION OF THE CROSS SECTIONAL AREA FOLLOWED BY A BENDING OVERLOAD. 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).

Description of Event or Problem · 1

SAME CASE AS MDR ID 2134265-2013-04289, 2134265-2013-04290. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, THE WIRE WAS DETACHED/SEPARATED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL (LAD) LEFT ANTERIOR DESCENDING. A ROTAWIRE EX SUPPORT GUIDEWIRE WAS SELECTED TO GUIDE THE BURR. IT WAS NOTED THAT ABLATION WAS PERFORMED AT LEFT CIRCUMFLEX ARTERY AND POST DILATATION WAS PERFORMED USING A NON-BSC BALLOON CATHETER AND THEN A PROMUS ELEMENT PLUS STENT 3.0 X 20 WAS DEPLOYED. THEN THE ROTAWIRE WAS ADVANCED BETWEEN THE LAD AND AT THE FIRST DIAGONAL BRANCH, AND ABLATION WAS PERFORMED AT OSTIAL PART OF LAD. WHEN ATTEMPTING TO PERFORM 3RD ABLATION THE ROTAWIRE WAS DETACHED. THE DETACHED WIRE WAS REMOVED USING A NON-BSC DEVICE. AFTER REMOVING THE DETACHED WIRE ANOTHER ABLATION WAS PERFORMED USING A ROTABURR 1.5 AND ANOTHER ROTAWIRE EX SUPPORT GUIDEWIRE. UPON 4TH ABLATION, IT WAS THEN NOTED THAT ANOTHER ROTAWIRE WAS DETACHED AT FIRST DIAGONAL BRANCH. THE DETACHED WIRE WAS NOT REMOVED FROM THE PATIENT¿S BODY. POST DILATATION WAS PERFORMED USING A NON-BSC PRODUCT AT THE OSTIAL PART OF THE FIRST DIAGONAL BRANCH THEN ABLATION WAS DISCONTINUED. SAME PROCEDURE WAS PERFORMED TO LAD. POST DILATATION WAS PERFORMED AT THE MIDDLE AND PROXIMAL LAD USING A DIFFERENT NON-BSC BALLOON CATHETER. A PROMUS ELEMENT PLUS STENT 2.5 X 15MM WAS THEN DEPLOYED AT THE MIDDLE LAD WITH A NON-BSC BALLOON CATHETER. A NON-BSC STENT WAS DEPLOYED AT PROXIMAL LAD WITH A NON-BSC BALLOON CATHETER. THEN A KISSING BALLOON TECHNIQUE WAS PERFORMED FOR THE TREATMENT OF THE PROXIMAL LAD AND AT THE FIRST DIAGONAL BRANCH. HUGGING BALLOON TECHNIQUE WAS PERFORMED AND ADDITIONAL DILATATION WAS MADE AT THE PROXIMAL LAD WITH A NON-BSC BALLOON CATHETER. PROCEDURE WAS THEN COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION WAS GOOD.

Description of Event or Problem · 1

SAME CASE AS MDR ID 2134265-2013-04289, 2134265-2013-04290. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, THE WIRE WAS DETACHED/SEPARATED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL (LAD) LEFT ANTERIOR DESCENDING. A ROTAWIRE EX SUPPORT GUIDEWIRE WAS SELECTED TO GUIDE THE BURR. IT WAS NOTED THAT ABLATION WAS PERFORMED AT LEFT CIRCUMFLEX ARTERY AND POST DILATATION WAS PERFORMED USING A NON-BSC BALLOON CATHETER AND THEN A PROMUS ELEMENT PLUS STENT 3.0 X 20 WAS DEPLOYED. THEN THE ROTAWIRE WAS ADVANCED BETWEEN THE LAD AND AT THE FIRST DIAGONAL BRANCH, AND ABLATION WAS PERFORMED AT OSTIAL PART OF LAD. WHEN ATTEMPTING TO PERFORM 3RD ABLATION THE ROTAWIRE WAS DETACHED. THE DETACHED WIRE WAS REMOVED USING A NON-BSC DEVICE. AFTER REMOVING THE DETACHED WIRE ANOTHER ABLATION WAS PERFORMED USING A ROTABURR 1.5 AND ANOTHER ROTAWIRE EX SUPPORT GUIDEWIRE. UPON 4TH ABLATION, IT WAS THEN NOTED THAT ANOTHER ROTAWIRE WAS DETACHED AT FIRST DIAGONAL BRANCH. THE DETACHED WIRE WAS NOT REMOVED FROM THE PATIENT¿S BODY. POST DILATATION WAS PERFORMED USING A NON-BSC PRODUCT AT THE OSTIAL PART OF THE FIRST DIAGONAL BRANCH THEN ABLATION WAS DISCONTINUED. SAME PROCEDURE WAS PERFORMED TO LAD. POST DILATATION WAS PERFORMED AT THE MIDDLE AND PROXIMAL LAD USING A DIFFERENT NON-BSC BALLOON CATHETER. A PROMUS ELEMENT PLUS STENT 2.5 X 15MM WAS THEN DEPLOYED AT THE MIDDLE LAD WITH A NON-BSC BALLOON CATHETER. A NON-BSC STENT WAS DEPLOYED AT PROXIMAL LAD WITH A NON-BSC BALLOON CATHETER. THEN A KISSING BALLOON TECHNIQUE WAS PERFORMED FOR THE TREATMENT OF THE PROXIMAL LAD AND AT THE FIRST DIAGONAL BRANCH. HUGGING BALLOON TECHNIQUE WAS PERFORMED AND ADDITIONAL DILATATION WAS MADE AT THE PROXIMAL LAD WITH A NON-BSC BALLOON CATHETER. PROCEDURE WAS THEN COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION WAS GOOD.

Description of Event or Problem · 1

SAME CASE AS MDR ID 2134265-2013-04289, 2134265-2013-04290. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, THE WIRE WAS DETACHED/SEPARATED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL (LAD) LEFT ANTERIOR DESCENDING. A ROTAWIRE EX SUPPORT GUIDEWIRE WAS SELECTED TO GUIDE THE BURR. IT WAS NOTED THAT ABLATION WAS PERFORMED AT LEFT CIRCUMFLEX ARTERY AND POST DILATATION WAS PERFORMED USING A NON-BSC BALLOON CATHETER AND THEN A PROMUS ELEMENT PLUS STENT 3.0 X 20 WAS DEPLOYED. THEN THE ROTAWIRE WAS ADVANCED BETWEEN THE LAD AND AT THE FIRST DIAGONAL BRANCH, AND ABLATION WAS PERFORMED AT OSTIAL PART OF LAD. WHEN ATTEMPTING TO PERFORM 3RD ABLATION THE ROTAWIRE WAS DETACHED. THE DETACHED WIRE WAS REMOVED USING A NON-BSC DEVICE. AFTER REMOVING THE DETACHED WIRE ANOTHER ABLATION WAS PERFORMED USING A ROTABURR 1.5 AND ANOTHER ROTAWIRE EX SUPPORT GUIDEWIRE. UPON 4TH ABLATION, IT WAS THEN NOTED THAT ANOTHER ROTAWIRE WAS DETACHED AT FIRST DIAGONAL BRANCH. THE DETACHED WIRE WAS NOT REMOVED FROM THE PATIENT¿S BODY. POST DILATATION WAS PERFORMED USING A NON-BSC PRODUCT AT THE OSTIAL PART OF THE FIRST DIAGONAL BRANCH THEN ABLATION WAS DISCONTINUED. SAME PROCEDURE WAS PERFORMED TO LAD. POST DILATATION WAS PERFORMED AT THE MIDDLE AND PROXIMAL LAD USING A DIFFERENT NON-BSC BALLOON CATHETER. A PROMUS ELEMENT PLUS STENT 2.5 X 15MM WAS THEN DEPLOYED AT THE MIDDLE LAD WITH A NON-BSC BALLOON CATHETER. A NON-BSC STENT WAS DEPLOYED AT PROXIMAL LAD WITH A NON-BSC BALLOON CATHETER. THEN A KISSING BALLOON TECHNIQUE WAS PERFORMED FOR THE TREATMENT OF THE PROXIMAL LAD AND AT THE FIRST DIAGONAL BRANCH. HUGGING BALLOON TECHNIQUE WAS PERFORMED AND ADDITIONAL DILATATION WAS MADE AT THE PROXIMAL LAD WITH A NON-BSC BALLOON CATHETER. PROCEDURE WAS THEN COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION WAS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
280572	ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM	CATHETER, CORONARY, ATHERECTOMY	MCX	BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)	H802232390010	15685531

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	STENT: PROMUSELMNET3.0X20\| GUIDEWIRE: SION BLUE\| GUIDING CATHETER: LAUNCHER EBU3.5SH\| BALLOON CATHETER: NC TREK