MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ENCORE BALLOON CATHETER INFLATION DEVICE; SYRINGE, BALLOON INFLATION

Model Number M001151050

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that a foreign object was present inside the device syringe.An encore balloon catheter inflation device was selected for use.During unpacking, it was noted that a foreign object of dirt was found inside the syringe.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the encore unit was returned with a white stain on the side of the device, the stain was noted to be on the inside of the clear housing and on the outside of the barrel.The stain did not obstruct the graduation marks in the barrel.Excess of silicone in the flexcil line and within the barrel of the device was observed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is user preference issue as the product met specification but the user was reportedly dissatisfied with the function, performance, or appearance of the product.(b)(4).

Event Description

It was reported that a foreign object was present inside the device syringe.An encore balloon catheter inflation device was selected for use.During unpacking, it was noted that a foreign object of dirt was found inside the syringe.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: ENCORE BALLOON CATHETER INFLATION DEVICE
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6963937
• MDR Text Key: 90659142
• Report Number: 2134265-2017-10428
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• PMA/PMN Number: K955869
• 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,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2019
• Device Model Number: M001151050
• Device Catalogue Number: 15-105
• Device Lot Number: 0020893267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• 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