MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING? SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939148301510

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2015

Event Type  malfunction  

Event Description

Same case as mdr id: 2134265-2015-04657.It was reported that tip detachment and catheter entrapment occurred.The target lesion was located in the anterior tibial artery.After a v-18 guide wire crossed the lesion, a 3.0mm x150mm x150cm sterling¿ sl balloon catheter was advanced for dilation.After the first inflation, it was noted that the distal tip of the balloon catheter was still intact but it was falling off.The balloon catheter and the guide wire were successfully removed completely from the patient's body.Outside the patient's body, the physician removed the v-18 guide wire from the balloon catheter, however, it was noted to be stuck inside the balloon catheter.The physician then pulled both ends of the balloon catheter (hub and distal tip) and the distal tip of the balloon catheter had fallen off completely.The procedure was completed using another balloon catheter and angioplasty was performed.No patient complications were reported and the patient¿s status was fine.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was not received for analysis.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).

• Brand Name: STERLING? SL
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4916315
• MDR Text Key: 6013066
• Report Number: 2134265-2015-04490
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: H74939148301510
• Device Catalogue Number: 39148-30151
• Device Lot Number: 17854613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2015
• 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
• Treatment: V-18 GUIDE WIRE