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

Model Number H74939032102080

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Returned product consisted of a sterling balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.There is a kink in the shaft 21.5cm from the distal tip.Functional testing was carried out by attaching an inflation device filled with water to the hub of the complaint device, and inflating the device to rated burst pressure (rbp).The sterling device inflated and held pressure for 5 minutes without leaking.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that air was present in the balloon during inflation.A 10.0mmx20mmx80cm (5f) sterling¿ balloon catheter was advanced for dilatation.However, during the procedure, the physician noticed that air was present inside the balloon.The device was completely removed from the patient.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.

• 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: 6825641
• MDR Text Key: 83869088
• Report Number: 2134265-2017-08418
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2017

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: 07/31/2019
• Device Model Number: H74939032102080
• Device Catalogue Number: 39032-10208
• Device Lot Number: 19485396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• 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