MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿; CATHETER, PERCUTANEOUS

Model Number H74939031404010

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4). the device was not returned for analysis.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that balloon rupture occurred.Vascular access was obtained using ipsilateral antegrade approach via the right femoral artery.The target lesion was located in the moderately tortuous and moderately calcified right popliteal artery.After a guide wire crossed the lesion, a 4.0mmx40mmx135cm (4f) sterling¿ balloon catheter was advanced for dilatation.However, during the first inflation at 6 atmospheres, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with a 4.0mmx60mm sterling¿ balloon catheter.No patient complications nor injuries were reported.

• Brand Name: STERLING¿
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7154016
• MDR Text Key: 96126468
• Report Number: 2134265-2017-12846
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K053118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: H74939031404010
• Device Catalogue Number: 39031-40401
• Device Lot Number: 18619260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1