MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number M001BP90620B0

Device Problems Cutter/Blade (777); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  Malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4).

Event Description

It was reported that blade detachment occurred. The 80% stenosed target lesion was located in the moderately tortuous non-calcified subclavian vein. A 6. 00mm/ 2. 0cm/ 90cm peripheral cutting balloon¿ was selected for use along with a 6fr sheath and 0. 018 guidewire. The device was prepped and introduced into the patient. The device was inflated at nominal pressure and some recoil was suspected during applying pressure process. Dilatation was performed five times in the same area at nominal pressure. A good dilatation of the lesion area was obtained. When withdrawing the balloon catheter from the patient's body, it was noted that one blade came off the balloon. No resistance was felt during removal. Consequently, the physician performed fluoroscopy and ct examination and confirmed no blade was left inside the patient's body. Furthermore, the physician performed flushing of the sheath to search for the blade; however, the blade was not found. Lastly, the blade was searched inside the tray after but still not found. There was no abnormality or symptoms observed from the patient. The procedure was completed with this device. No patient complications were reported and patient's status was stable.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7407269
• MDR Text Key: 104835142
• Report Number: 2134265-2018-02724
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,DISTRI

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/09/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 11/01/2019
• Device MODEL Number: M001BP90620B0
• Device Catalogue Number: BP906020B
• Device LOT Number: 0021324397
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial