FDA Adverse Event Malfunction Summary report: N

SMALL PERIPHERAL CUTTING BALLOON¿

MDR report key: 3080621 · Received April 26, 2013

Report

Report Number: 2134265-2013-02764
Event Type: Malfunction
Date Received: April 26, 2013
Date of Event: April 1, 2013
Report Date: April 1, 2013
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: LOX
PMA / PMN Number: P950020
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE MIDSHAFT AT THE EXCHANGE PORT SITE. AN EXAMINATION OF THE BREAK SITE FOUND THAT THE EXTRUSION WAS STRETCHED. NO ISSUES WERE NOTED WITH THE BALLOON. THE ACTUAL BALLOON PROTECTOR CAP WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS PERIPHERAL INTERVENTION PROCEDURE A CATHETER BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. DURING PREPARATION AS THE 4.0 X 1.5CM SMALL PERIPHERAL FLEXTOME CUTTING BALLOON PROTECTION SHEATH WAS BEING REMOVED, THE CATHETER BROKE APPROXIMATELY 20CM FROM THE DISTAL END. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD..

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
182940	SMALL PERIPHERAL CUTTING BALLOON¿	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - GALWAY	M001BPM4015140F0	15586005

Patients

Seq	Age	Sex	Outcome	Treatment
1