MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number M004IDERFS96200

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

Patient Problems Abdominal Pain (1685); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

(b)(6) clinical study.The index ablation procedure was completed on (b)(6) 2021.Access was gained via non-boston scientific access sheath(s), and unspecified non-boston scientific diagnostic catheter(s).Ablation was performed using three intellanav stablepoint catheters, mapping was also performed with an intellamap orion high resolution mapping catheter.No patient complications or product performance issues were reported.Three days following the index procedure, the patient experienced bloating and abdominal pain.Patient underwent ct-scan of the abdomen and blood work, which were "negative".Patient was given intravenous hydromorphone.Patient was discharged the same day.

Event Description

Newton af clinical study: the index ablation procedure was completed on 04oct2021.Access was gained via non-boston scientific access sheath(s), and unspecified non-boston scientific diagnostic catheter(s).Ablation was performed using three intellanav stablepoint catheters, mapping was also performed with an intellamap orion high resolution mapping catheter.No patient complications or product performance issues were reported.Three days following the index procedure, the patient experienced bloating and abdominal pain.Patient underwent ct-scan of the abdomen and blood work, which were "negative".Patient was given intravenous hydromorphone.Patient was discharged the same day.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.

• Brand Name: INTELLANAV STABLEPOINT OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12780995
• MDR Text Key: 280538263
• Report Number: 2134265-2021-14086
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: M004IDERFS96200
• Device Lot Number: 0027561039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ABBOTT/ST. JUDE MEDICAL DIAGNOSTIC CATHETER(S); ABBOTT/ST. JUDE MEDICAL DIAGNOSTIC CATHETER(S); INTELLAMAP ORION; INTELLAMAP ORION; INTELLANAV STABLEPOINT; INTELLANAV STABLEPOINT; TERUMO PINNACLE ACCESS SHEATH(S); TERUMO PINNACLE ACCESS SHEATH(S)
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 86 KG