MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	8121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was thrombus present in the patient.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a watchman flx laa closure device & delivery system (wds) were selected to be used.The physician successfully performed the transseptal puncture and then inserted the was into the patient.The impulse pigtail catheter was inserted to help position the was in the laa of the patient.The impulse pigtail catheter was then removed from the patient, and it was noted that there were clots all over the device.The physician aspirated the was, but no thrombus remained in the patient.The physician continued the procedure using the same was.The wds was inserted, and the closure device was deployed in the patient.After all release criteria was met the closure device was released from the core wire of the wds and successfully implanted in the laa of the patient.The patient did not experience any other complications and is expected to make a full recovery.
Additional Manufacturer Narrative
Device analysis: the returned device consisted of an impulse diagnostic catheter.Inspection of the device presented no damage or irregularities to the device.Product analysis did not confirm the reported event, as the clinical circumstances cannot be replicated.
Event or Problem Description
It was reported that there was thrombus present in the patient.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a watchman flx laa closure device & delivery system (wds) were selected to be used.The physician successfully performed the transseptal puncture and then inserted the was into the patient.The impulse pigtail catheter was inserted to help position the was in the laa of the patient.The impulse pigtail catheter was then removed from the patient, and it was noted that there were clots all over the device.The physician aspirated the was, but no thrombus remained in the patient.The physician continued the procedure using the same was.The wds was inserted, and the closure device was deployed in the patient.After all release criteria was met the closure device was released from the core wire of the wds and successfully implanted in the laa of the patient.The patient did not experience any other complications and is expected to make a full recovery.

• Brand Name: IMPULSE GUIDE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19643570
• Report Number: 2124215-2024-37925
• Device Sequence Number: 7734062
• Product Code: DQO
• UDI-Device Identifier: 08714729200338
• UDI-Public: 08714729200338
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K120495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2026
• Device Model Number: 8121
• Device Catalogue Number: 8121
• Device Lot Number: 0060556969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Race: White