MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

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

Patient Problem No Code Available (3191)

Event Date 03/29/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding the facility, a supplemental 3500a report will be submitted to the fda.Initial reporter phone: (b)(6).A request has been sent to clarify the facility name and address.However, no further information has been made available.(b)(4).

Event Description

During a clinical trial sponsored by biosense webster inc.(bwi), it was reported that a patient underwent an atrial fibrillation (afib) ablation procedure on (b)(6) 2020 with a thermocool® smart touch® sf bi-directional navigation catheter and developed acute paralytic gastric dilation (nerve injury) requiring prolonged hospitalization.During the procedure, the ablation was conducted with the thermocool® smart touch® sf bi-directional navigation catheter.No bwi product malfunctions were reported.The procedure was successfully completed without immediate patient consequence.On post-procedure day 3 (b)(6) 2020), the patient developed acute paralytic gastric dilation (nerve injury).There¿s no indication that any medical/surgical intervention was provided.Prolonged hospitalization was required.Issue was resolved.The principal investigator assessed the event as serious, not related to the device and related to the procedure.No further information is available.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

On 8/31/2020, biosense webster inc.Received additional information about the patient and event.It was reported the patient in this procedure was a 54 year old male and the patients condition improved.It was also reaffirmed that the adverse event was discovered post use.Patient¿s health history was reported with hyperuricemia, iron deficiency anemia and has been added to field b6.On 9/24/2020, the name of the facility in which this adverse event occurred was reported as ¿(b)(6)¿.As such, the appropriate fields in section e1.Initial reporter have been populated.E1.Initial reporter: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

Correction: on (b)(6) 2020 it was noticed the following information was inadvertently omitted from the 3500a supplemental mdr #1: device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).Additional correction: please note, this procedure was not part of a biosense webster inc.(bwi) sponsored clinical trial as previously reported.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10304063
• MDR Text Key: 200271721
• Report Number: 2029046-2020-00905
• Device Sequence Number: 1
• Product Code: LPB
• 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
• Report Date: 06/22/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 08/31/2020; 10/28/2020
• Supplement Dates FDA Received: 09/29/2020; 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR