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

Model Number	M004P4500THK20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.The returned device matches the upn and lot number provided by the customer.There is dried body fluid on the handle and on the distal tip.All three ring seals are compromised; there is dried body fluid along the distal side of ring 3.All seals appear to have had adequate adhesive applied.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Tip motion was evaluated against the specified curve template.Both right and left curve tests failed.The tip does not curve to the left.X-rays showed evidence of guide coil collapse under the handle strain relief and near the strain relief.No abnormalities were noted in the distal end.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is supplier manufacturing process design as the design or validation of a suppliers manufacturing process was not sufficient to ensure the finished device met the intent of the design.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 29-nov-2017.It was reported that the steering mechanism broke.The target lesion was located in the atrium.A blazer prime® xp was selected for use.During procedure, the steering mechanism broke.The procedure was completed with another of the same device.No patient complications reported.However, device analysis revealed that all seals on the electrodes were compromised.

• Brand Name: BLAZER PRIME® XP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7110197
• Report Number: 2134265-2017-12451
• Device Sequence Number: 1311012
• Product Code: OAD
• UDI-Device Identifier: 08714729802334
• UDI-Public: 08714729802334
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: M004P4500THK20
• Device Catalogue Number: P4500THK2
• Device Lot Number: 0020956839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR