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

Model Number H74939032404040

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: 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 factors.(b)(4).

Event Description

It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in an anastomosis site of an arteriovenous fistula in the moderately tortuous and severely calcified forearm vessel.A 6fr non bsc sheath was placed and a 4.0mmx40mmx40cm sterling balloon catheter was advanced to the lesion.The balloon was inflated for 20 seconds however it ruptured at approximately 14 atmospheres on the second inflation.The device was removed from the sheath and the procedure was completed using a 4mm small peripheral cutting balloon (spcb).No patient complications were reported and the patient's status was good.

• 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: 5318490
• MDR Text Key: 34138171
• Report Number: 2134265-2015-08827
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K053116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2015
• Device Model Number: H74939032404040
• Device Catalogue Number: 39032-40404
• Device Lot Number: 15655376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2012
• 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: INTRODUCER SHEATH: 6FR MOSQUITO