MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. UNK_COOLFLOW TUBING SET; CATHETER, ELECTRODE RECORDING

Catalog Number UNK_COOLFLOW TUBING SET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Thromboembolism (2654)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure with a multi-electrode rf balloon, a multi-electrode circular diagnostic catheters, and a cool flow irrigation tubing set and developed asymptomatic cerebral embolism requiring an unspecified treatment.At an unspecified point, the patient developed asymptomatic cerebral embolism.An unspecified treatment was provided.Patient¿s outcome is unknown.Principal investigator assessed the event as mild in severity, not serious, possible related to the multi-electrode rf balloon catheter, unlikely related to the multi-electrode circular diagnostic, possible index procedure related.On (b)(6) 0218, additional information was received which indicates the issue was assessed as possibly related to the bwi non-investigational device cool flow irrigation tubing set.As such, the awareness date of the reportable event has been reset to (b)(6) 2018.

Manufacturer Narrative

On 4/8/2019, it was noticed that a correction is needed for mis-information reported under supplemental mdr # 2.In supplemental mdr # 2 it was reported that the principal investigator reassessed the event as ¿probable¿ related to the multi-electrode rf balloon catheter.However, this is incorrect.The relationship of the event remains ¿possible¿ to the multi-electrode rf balloon catheter.The only update received on 12/18/2018 was that of the principle investigator reassessed the relationship of the primary study procedure as ¿probable¿.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On 12/13/2018, further review of the reported event determined the adverse event required to be reclassified as "thromboembolism".As such, the patient code has been updated from code 1697 - air embolism to code 2654 - thromboembolism.Manufacturer's ref # (b)(4).

Manufacturer Narrative

On 12/18/2018, additional information about the event was received.It was reported the principal investigator reassessed the event as "probable" related to the multi-electrode rf balloon catheter.The relationship to primary study procedure was updated from possible to probable.Manufacturer¿s ref #: (b)(4).

Manufacturer Narrative

On 5/9/2019, additional information was received indicating the patient¿s outcome for the reported asymptomatic cerebral embolism is now recovered/resolved.Manufacturer's ref # (b)(4).

• Brand Name: UNK_COOLFLOW TUBING SET
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8127561
• MDR Text Key: 129151767
• Report Number: 2029046-2018-02401
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/06/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_COOLFLOW TUBING SET
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/13/2018; 12/18/2018; 04/08/2019; 05/09/2019
• Supplement Dates FDA Received: 12/20/2018; 01/16/2019; 04/08/2019; 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 51 YR