ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

Report

Report Number: 2134265-2011-00666
Event Type: Death
Date Received: March 9, 2011
Date of Event: February 4, 2011
Report Date: February 9, 2011
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA
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). UPDATED: CATALOG/MODEL #, DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, DEVICE MANUFACTURED DATE, METHOD CODES, RESULT CODES, CONCLUSION CODES. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS RECEIVED WITH ITS ORIGINAL POUCH, OUTSIDE THE HOOP. THE DEVICE WAS RETURNED ATTACHED TO THE ROTABLATOR SYSTEM. VISUAL EXAMINATION IDENTIFIED SEVERAL KINKS AT THE PROXIMAL END OF THE DEVICE. OUTER DIAMETER MEASUREMENTS WERE WITHIN SPECIFICATIONS. A CORE WIRE FRACTURE WAS NOTED APPROXIMATELY 13.5CM FROM THE DISTAL END. SEM FRACTURE ANALYSIS REVEALED THE FRACTURE OCCURRED IN A BENDING OVERLOAD DIRECTION AS A RESULT OF A REDUCTION IN THE CROSS SECTIONAL AREA OF THE WIRE, DUE TO SURFACE WEAR. NO OTHER MATERIAL ANOMALIES WERE NOTED. 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 MFR.: 2134265-2011-00665. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE AND VESSEL PERFORATION OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN A NON TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX (CX) ARTERY. THE LESION WAS SUCCESSFULLY ABLATED TWICE, WITH A 2.0MM ROTALINK BURR. THEN, THE 1.5MM ROTALINK BURR WAS ADVANCED TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ROTATIONAL SPEED OF THE BURR WAS 200,000RPMS AND DURING THE FIRST ATTEMPT TO ABLATE, THE ROTAWIRE GUIDE WIRE FRACTURED APPROXIMATELY 7CM PROXIMAL TO THE DISTAL END. THE BURR 'DISLOCATED AND MOVED INTO THE CX', PERFORATING THE VESSEL. THE BURR WAS RETRACTED AND REMOVED FROM THE PATIENT. RESUSCITATION WAS PERFORMED ON THE PATIENT. THE GUIDE WIRE WAS LEFT IN THE PATIENT AND THE PATIENT WENT TO SURGERY. DURING SURGERY THE GUIDE WIRE WAS REMOVED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT EXPIRED 24 DAYS AFTER THE PROCEDURE DUE TO HYPOXIC CEREBRAL DAMAGE.

Description of Event or Problem · 1

SAME CASE AS MFR.: 2134265-2011-00665. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE AND VESSEL PERFORATION OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN A NON TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX (CX) ARTERY. THE LESION WAS SUCCESSFULLY ABLATED TWICE, WITH A 2.0MM ROTALINK BURR. THEN, THE 1.5MM ROTALINK BURR WAS ADVANCED TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ROTATIONAL SPEED OF THE BURR WAS 200,000RPMS AND DURING THE FIRST ATTEMPT TO ABLATE, THE ROTAWIRE GUIDE WIRE FRACTURED APPROXIMATELY 7CM PROXIMAL TO THE DISTAL END. THE BURR "DISLOCATED AND MOVED INTO THE CX", PERFORATING THE VESSEL. THE BURR WAS RETRACTED AND REMOVED FROM THE PATIENT. RESUSCITATION WAS PERFORMED ON THE PATIENT. THE GUIDE WIRE WAS LEFT IN THE PATIENT AND THE PATIENT WENT TO SURGERY. DURING SURGERY THE GUIDE WIRE WAS REMOVED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT EXPIRED 24 DAYS AFTER THE PROCEDURE DUE TO HYPOXIC CEREBRAL DAMAGE.

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	13430373

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Death\| R	1.5MM ROTALINK BURR