MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR VL, SENSOR ENABLED CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D-AVSE-DF20-V1525
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Respiratory Distress (2045); Tricuspid Regurgitation (2112); Regurgitation, Valvular (2335); Low Oxygen Saturation (2477)
Date of Event	09/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
During right atrial geometry, the catheter became lodged in the tricuspid valve apparatus (chordae tendineae).The catheter became got caught in the chordae tendineae and when pulling the catheter back into the sheath to free the catheter, the papillary muscle was ruptured.The rupture caused a prolapse of the tricuspid valve (tv) and regurgitation.The patient was stable under general anesthesia, so the procedure continued.Pulmonary vein isolation and a cti line was completed using the same advisor vl as the diagnostic catheter.The physician believes the tricuspid valve regurgitation was a result of the catheter getting stuck in the chordae and rupturing the papillary muscle, causing prolapse of the tv.Combined with the previously known pfo, this led to patient oxygen desaturation.After the ablation procedure was completed, a pfo occluder was inserted into the pfo to prevent further desaturation.The patient may need valve repair surgery in the future.There were no performance issues with the abbott device.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported entrapment and subsequent regurgitation could not be conclusively determined.

• Brand Name: ADVISOR VL, SENSOR ENABLED CIRCULAR MAPPING CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10532520
• Report Number: 3005334138-2020-00418
• Device Sequence Number: 3074080
• Product Code: DRF
• UDI-Device Identifier: 05415067027283
• UDI-Public: 05415067027283
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192037
• 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,Followup
• Report Date (Section B): 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: D-AVSE-DF20-V1525
• Device Catalogue Number: D-AVSE-DF20-V1525
• Device Lot Number: 7593485
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 09/18/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 09/15/2020; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 94