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

Model Number	M0045031TH0
Medical Device Problem Code	Radio Signal Problem (1511)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual inspection of the returned device revealed that there is a kink located approximately 103cm from the distal tip which is approximately 7cm from the end of the strain relief.The ring 1 seal is compromised; there is body fluid on the edges of the ring.Electrical testing also revealed that r1 is open and no shorts were found.X-rays did not reveal any abnormalities in the distal tip.The distal section was dissected.There is body fluid under the r1 ring.Inspection after dissection showed a broken wire near the weld to the ring 1 electrode.A segment of the wire was still welded to the ring 1 electrode.A dhr (device history record) review was performed and no deviation was found.The most probable root cause of the reported difficulty is a design constraint of the product.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 30-aug-2017.It was reported that no catheter signal occurred.A 7/110/2.5/7-4 quad blazer® ii htd was selected for use.During procedure, it was noticed that the signal was not visible.Furthermore, the recording equipment settings and cable were changed but the signal is still not visible.Finally, the catheter was changed with another of the same to complete the procedure.No patient complications reported.However, device analysis revealed that the ring 1 seal is compromised and there is body fluid on the edges of the ring.

• Brand Name: BLAZER® II 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: 6868398
• Report Number: 2134265-2017-09295
• Device Sequence Number: 762078
• Product Code: LPB
• UDI-Device Identifier: 08714729172048
• UDI-Public: (01)08714729172048(17)20190708(10)0019430824.
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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: 07/08/2019
• Device Model Number: M0045031TH0
• Device Catalogue Number: 5031TH
• Device Lot Number: 0019430824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR