MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER PRIME? HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M004EPTP5031TH0

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2014

Event Type  malfunction  

Event Description

Reportable based on product analysis completed on (b)4) 2014.It was reported that the catheter was not possible to bend.A 7-110-2.5-7-4 blazer prime¿ htd was selected to ablate the unspecified target lesion.During introduction, it was noted that the catheter was not possible to bend.The procedure was completed with another of the same device.No patient complications reported.However, device analysis revealed the adhesive of ring 2 and 3 was broken.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned for analysis.Visual examination of the device revealed a bent at the distal section at 6cm from the tip while in the neutral position.The adhesive of the ring 2 and 3 was found broken.The steering knob and the tension control knob functioned properly on both lock and unlock positions.The right and left curves are not placed in the template shaded areas, the device failed the dimensional test.The device was opened finding the guide coil collapsed inside the handle, next to the adjustment knob, also the shaft was opened finding two more sections collapsed at 5cm and 6cm from the handle.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

• Brand Name: BLAZER PRIME? HTD
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3909724
• MDR Text Key: 16182181
• Report Number: 2134265-2014-03808
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P920047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2016
• Device Model Number: M004EPTP5031TH0
• Device Catalogue Number: EPTP5031TH
• Device Lot Number: 16592562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2013
• 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