MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) BALLOON CATHETER INFLATION DEVICES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number UNK614

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause was unable to be determined.  (b)(4).

Event Description

Same case as mdr id: 2134265-2017-02280 it was reported that the sterility was compromised.An encore balloon catheter inflation device was selected for use.During unpacking, it was noted that the device packaging was not opening well.The backing paper was ripping and separating causing the sterility to be compromised.No patient was involved in this case.

• Brand Name: BALLOON CATHETER INFLATION DEVICES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6414356
• MDR Text Key: 70322977
• Report Number: 2134265-2017-02279
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K875064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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