MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) BLAZER PRIME® XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004P4500THK20

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a hole in the sterile package was noted.A 7-110-2.5-8-8 k2 blazer prime® xp was selected to treat the target lesion.After they pulled the device out off the shelf, it was noted that the box was damaged.While opening the device, it was further noted that the actual damage went through the catheter as there was a small puncture hole through the sterile packaging and then the part where the catheter connects to the handle broke off.The procedure was complete with another with the same device.No patient complications reported.Device never went inside the patient's body.

Manufacturer Narrative

Device evaluated by manufacturer: device was returned for analysis.The device has the box damaged (bent and with a hole) at 24 cm from the bottom of the box.This area matched with the damage in the pouch (hole) and the damage in the device (handle broken in the strain relief).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that a hole in the sterile package was noted.A 7-110-2.5-8-8 k2 blazer primep was selected to treat the target lesion.After they pulled the device out off the shelf, it was noted that the box was damaged.While opening the device, it was further noted that the actual damage went through the catheter as there was a small puncture hole through the sterile packaging and then the part where the catheter connects to the handle broke off.The procedure was complete with another with the same device.No patient complications reported.Device never went inside the patient's body.

• Brand Name: BLAZER PRIME® XP
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5269614
• MDR Text Key: 32743277
• Report Number: 2134265-2015-08282
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

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 Model Number: M004P4500THK20
• Device Catalogue Number: P4500THK2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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