MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIA; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	86721
Medical Device Problem Codes	Material Perforation (2205); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported there was a separation in the insulation of the catheter.During an ablation procedure for paroxysmal supraventricular tachycardia (psvt) with a radia catheter, the catheter had a fracture and separation of insulation material on the curve.The physician completed the procedure using another catheter.No patient complications occurred.The device will be returned for analysis.
Additional Manufacturer Narrative
The device was returned to boston scientific for evaluation.Visual inspection showed the device had damage in the shaft near the distal end, between ring #10 and ring #11.One steering wire was partially exposed through the shaft.A kink was observed in the same location.Functional test showed that the thumbwheel functioned properly.No abnormal resistance was felt when actuating the steering mechanism.The test curve passed; left and right curves were placed in the template specified areas.The device passed the dimensional test.X-ray inspection confirmed the damaged in the shaft near the distal end of the device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported there was a separation in the insulation of the catheter.During an ablation procedure for paroxysmal supraventricular tachycardia (psvt) with a radia catheter, the catheter had a fracture and separation of insulation material on the curve.The physician completed the procedure using another catheter.No patient complications occurred.The device will be returned for analysis.

• Brand Name: RADIA
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10138565
• Report Number: 2134265-2020-07807
• Device Sequence Number: 11212717
• Product Code: DRF
• UDI-Device Identifier: 08714729877950
• UDI-Public: 08714729877950
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K091370
• 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,Followup
• Report Date (Section B): 07/30/2020

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: 05/14/2022
• Device Model Number: 86721
• Device Catalogue Number: 86721
• Device Lot Number: 0023795453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/30/2020
• Patient Sequence Number: 1