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

Model Number	87089
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
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 that body fluid ingress occurred.After an ablation procedure with a woven diagnostic electrode catheter, the physician cut the device after usage to collect the electrode part and leakage of blood was confirmed from the inside of the cut part.There was no problem with regards to the usage during the procedure.The procedure was completed with this device and there was no serious injury or adverse patient effects.
Additional Manufacturer Narrative
The device was returned for analysis.Only a sample of the original device was returned.The sample consisted of the most distal portion of the catheter (approximately 18cm) that included all five electrodes.The proximal section (dissected) end of the sample was confirmed to have residual blood.The most likely cause of blood to enter the interior of the catheter is from improperly swaged electrodes.The sample was inspected under magnification and found that all electrodes were swaged to the shaft.The electrode to shaft transitions were smooth and the distal electrode was round and smooth.All five electrodes ods were measured using a calibrated micrometer and were within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that body fluid ingress occurred.After an ablation procedure with a woven diagnostic electrode catheter, the physician cut the device after usage to collect the electrode part and leakage of blood was confirmed from the inside of the cut part.There was no problem with regards to the usage during the procedure.The procedure was completed with this device and there was no serious injury or adverse patient effects.

• Brand Name: WOVEN
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8431814
• Report Number: 2134265-2019-02673
• Device Sequence Number: 11028386
• Product Code: DRF
• UDI-Device Identifier: 08714729899501
• UDI-Public: 08714729899501
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/11/2019

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: 09/28/2023
• Device Model Number: 87089
• Device Catalogue Number: 87089
• Device Lot Number: GFCX0876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 06/11/2019
• Patient Sequence Number: 1