MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMTCH SF BID, TC, D-F; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Nerve Damage (1979)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30448180m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).Manufacturer's ref.# (b)(4).

Event Description

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure on (b)(6) 2021, on (b)(6) 2021 the patient returned and was hospitalized with gastric dilatation.The physician¿s commented that during ablation of the posterior wall isolation, it may have affected the esophageal vagus nerve.No further information is available.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

On 5/11/2021, biosense webster inc.Received additional information indicating the patient was a 70 year-old-female.The physician¿s opinion on the cause of this adverse event was procedure related.The event occurred post use of biosense webster products.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).

• Brand Name: THMCL SMTCH SF BID, TC, D-F
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11436223
• MDR Text Key: 240656664
• Report Number: 2029046-2021-00312
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30448180M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Other
• Patient Age: 70 YR