MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO NAV ECO CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number	D134903
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded.Therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.No code available was used to represent surgical intervention.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure on which a lasso nav catheter was used, and a medical device entrapment occurred requiring surgical intervention.During the mapping phase of the left atrium, the lasso catheter accidently went from the mitral valve into the left ventricle.All attempts to get the lasso back into the left atrium failed.The patient required surgical intervention so the catheter could be retrieved from the heart.There¿s no information regarding extended hospitalization, patient¿s outcome, or the physician¿s causality opinion.The catheter was not stuck or jammed in a full deflected position.The knob/piston was not unable to be turned and/or pushed up and down.No additional details were provided.
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure on which a lasso nav catheter was used, and a medical device entrapment occurred requiring surgical intervention.Additional information was received on 4/21/2020, indicating the patient required minimally invasive surgical intervention (no open-heart surgery), so the catheter could be retrieved from the heart.They tried to get the catheter back into sheath.A second sheath was used to help push the trabecula¿s smoothly away.No damage to the patient¿s heart valve occurred.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Additional Manufacturer Narrative
During an internal review on 6/12/2020, a correction was noted on the 3500a initial as ¿b2.Is required intervention¿ should have been processed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: LASSO NAV ECO CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9661856
• Report Number: 2029046-2020-00183
• Device Sequence Number: 3675318
• Product Code: DRF
• UDI-Device Identifier: 10846835009675
• UDI-Public: 10846835009675
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: D134903
• Device Catalogue Number: D134903
• Device Lot Number: 30292085L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 04/21/2020; 06/12/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 05/19/2020; 06/12/2020
• 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: Required Intervention