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

Model Number H74939031602210

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2015

Event Type  malfunction  

Event Description

It was reported that balloon tear occurred.Vascular access was obtained via the right femoral artery using a 6f 90cm non bsc introducer sheath.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left superficial femoral artery.Angiography was performed and a non bsc guide wire was advanced and crossed the lesion.Then a non bsc stent deployed and a 6.0mmx220mmx150cm sterling¿ balloon catheter was advanced for dilation.The balloon was inflated at 4 atmospheres for 3 seconds on the first inflation however contrast media leakage was confirmed on angiogram.The device was removed from the patient and it was found out that the balloon was cracked longitudinally.The procedure was completed using another of the same device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Age at time of event: 18 years or older.  (b)(4).The complaint device 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 operational context as device performance was limited due to anatomical procedural factor.(b)(4).

• Brand Name: STERLING?
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 4647859
• MDR Text Key: 5682139
• Report Number: 2134265-2015-01647
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K141150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: H74939031602210
• Device Catalogue Number: 39031-60221
• Device Lot Number: 17559190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2014
• 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: STENT: MISAGO; GUIDE WIRE: GAIA PV; INTRODUCER SHEATH: DESTINATION 6F 90CM