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

Model Number	M004P5031THK20
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr:unit received in a decontamination pouch, overall visual did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn and lot provided by the customer.The device was returned with a low voltage computer cable.Visual inspection revealed possible body fluid under r1 seal and what appears to be a blue fiber encased in the seal of r3.The steering knob and the tension control knob functioned properly on both lock and unlock positions.Electrical test was performed and found that r2 was open.No shorts were found.A portion of the proximal sheath was removed and the insulation of the r2 wire was removed.There is continuity from the r2 wire to the connector and an open between the r2 wire and ring 2.This indicates the open is in the distal end.Lifted ring 2 ¿ a portion of the r2 wire is attached to ring 2 and the connection appears to be secure.The distal sheath was removed proximal to ring 2 so that the ring 2 area was left intact.This revealed that the r2 wire has a fracture that is located at the end of where the wire insulation had been stripped.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).
Event or Problem Description
Reportable based on returned device analysis completed on december 5, 2016.It was reported that no electrograms displayed.The target location was the right atrium.During the procedure, no electrograms were displaying from the blazer prime® htd catheter and the cable had noise.The noise was resolved with exchanging the cable.The procedure was completed with another of the same catheter.No patient complications were reported and the patient's status is fine.However, returned device analysis revealed fluid under ring seal 1 and a blue fiber encased in the seal of r3.

• Brand Name: BLAZER PRIME® HTD
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6196040
• Report Number: 2134265-2016-11901
• Device Sequence Number: 185320
• Product Code: LPB
• UDI-Device Identifier: 08714729803591
• UDI-Public: (01)08714729803591(17)20190628(10)0019407867
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P920047
• 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): 12/05/2016

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: 06/28/2019
• Device Model Number: M004P5031THK20
• Device Catalogue Number: P5031THK2
• Device Lot Number: 0019407867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1