MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7580

Device Problems Inflation Problem (1310); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6). Device evaluated by mfr. : returned product consisted of a maverick 2 balloon catheter. The hypotube was fractured 48cm from hub, the fractured ends were ovaled indicating that the hypotube was kinked prior to fracturing. There were numerous kinks throughout the hypotube. The balloon was inflated by connecting a toughy and stopcock to the fractured end and pressurizing with an inflation device. The balloon maintained pressure for 5 minutes and there were no leaks observed.

Event Description

Reportable based on device analysis completed on 30dec2019. It was reported that shaft kink and inflation failure occurred. Vascular access was obtained via femoral artery. The target lesion was located in the severely tortuous and mildly calcified left circumflex coronary artery. A 2. 00mm x 12mm maverick balloon catheter was advanced for dilatation, but the shaft was kinked and the balloon could not inflate properly. The procedure was completed with a non-bsc balloon catheter. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed shaft separation.

• Brand Name: MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9590435
• MDR Text Key: 178032512
• Report Number: 2134265-2019-16796
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0023938972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial