MAUDE Adverse Event Report: Abbott Medical BRK¿ Transseptal Needle, 71 cm Length; Trocar

Model Number	407200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Cardiac Tamponade (2226)
Type of Reportable Event	Serious Injury
Event or Problem Description
In the chinese literature review, one publication ¿acute cardiac tamponade caused by misperforation of the aorta during transseptal puncture without thoracotomy¿a case report¿ states that: a 65-year-old male patient underwent an electrophysiological study.After placement of a coronary sinus (cs) mapping catheter and a right ventricular mapping catheter, tachycardia was induced.During tachycardia, the atrial electrogram at cs7-8 preceded activation, and ventricular stimulation delivered during the his refractory period advanced atrial activation, suggesting the presence of a left-sided accessory pathway.Following the first transseptal puncture (tsp), an st ablation catheter (biosense webster) was advanced into the left atrium.Under the guidance of the carto 3 mapping system, ventricular pacing near the mitral annulus adjacent to cs7-8 demonstrated the earliest atrial activation.Radiofrequency energy was delivered at 30 w for 10 seconds; however, the tachycardia did not terminate.The ablation catheter was then withdrawn into the right atrium, and no satisfactory target site was identified along either the tricuspid annulus or within the coronary venous system.A second tsp was subsequently performed.An 8.5-f swartz sheath (st.Jude medical) was advanced approximately 2 cm, after which the transseptal needle was withdrawn and a guidewire was inserted (figure 1a).Under both 30° left anterior oblique and anteroposterior fluoroscopic views, the guidewire was noted to be oriented abnormally in a vertical direction (figures 1b-c).Simultaneously, the patient's oxygen saturation and blood pressure progressively declined, accompanied by marked dyspnea and weakened cardiac contractions, suggesting cardiac tamponade secondary to inadvertent aortic puncture during tsp.The guidewire was secured in place, and the operator maintained slight tension on the dilator and sheath to tamponade the puncture site.Pericardiocentesis and autologous blood reinfusion were immediately performed.After induction of general anesthesia, transesophageal echocardiography (tee) and digital subtraction angiography (dsa) were used for procedural guidance.The guidewire was intentionally left within the aorta.Once the patient's hemodynamic status had stabilized, the sheath was withdrawn slowly and incrementally under tee and dsa guidance (figures 2a-d) to minimize potential displacement of blood clots attached to the devices.After the dilator had been completely withdrawn from the aorta (figure 2d), the sheath was stabilized, and the remaining guidewire within the aorta was gradually removed in the same stepwise manner (figure 2e).The patient was observed for 30 minutes, during which vital signs remained stable and tee showed no increase in pericardial effusion.The sheath and guidewire were then completely removed (figure 2f).Throughout the procedure, the cardiovascular surgical team remained on standby for emergency sternotomy if required.No significant hypotension occurred during sheath withdrawal, and no increase in pericardial effusion was detected by tee.The patient was discharged uneventfully 6 days after the procedure.Four months later, transthoracic echocardiography findings were normal, and the patient subsequently underwent successful catheter radiofrequency ablation.During more than 4 years of follow-up, through (b)(6) 2025, repeated evaluations revealed no evidence of late cardiac injury, and cardiac function had improved compared with baseline (new york heart association functional class ii).Discussion aortic injury is a rare but preventable complication of transseptal puncture.Prevention relies on meticulous procedural technique, multimodality imaging guidance, and accurate anatomical localization.In the present case, the patient had already developed clinical signs of cardiac tamponade, representing a life-threatening situation.To avoid secondary aortic injury during advancement or withdrawal of the dilator and sheath, neither immediate advancement nor immediate removal of the transseptal apparatus was attempted.Instead, the guidewire was left in place, and slight tension was applied to the sheath to facilitate temporary sealing of the vascular injury.Simultaneously, urgent pericardial drainage, autotransfusion, and aggressive fluid resuscitation were initiated.Tee was then introduced to monitor both the extent of pericardial effusion and the spatial relationship between the sheath and the aorta.Consequently, tee served as the primary intraoperative monitoring modality in this case.After the patient's hemodynamic condition stabilized and active bleeding was presumed to have decreased, a strategy of slow, stepwise traction was adopted.The sheath was first withdrawn gradually and incrementally while ensuring that the guidewire remained within the aorta.Once the dilator had exited the aorta, the sheath was fixed in position and the remaining guidewire was progressively removed.This approach was intended to minimize secondary injury associated with device manipulation.Throughout the withdrawal process, the patient was closely monitored for worsening pericardial effusion, and the strategy ultimately achieved a favorable clinical outcome.It was reported that an acute cardiac tamponade occurred, caused by inadvertent puncture of the aorta.A pericardiocentesis was performed.After the initial transseptal puncture, the non-abbott catheter could not reach the target ablation site.Another transseptal puncture was performed at a more anterior location to avoid overlapping with the initial transseptal puncture, but the aorta was inadvertently punctured.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the batch record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident of aortic perforation and cardiac tamponade could not be conclusively determined.

• Brand Name: BRK¿ Transseptal Needle, 71 cm Length
• Common Device Name: Trocar
• Manufacturer (Section D): Abbott Medical; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): Abbott Medical; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50258481
• Report Number: 3008452825-2026-00445
• Device Sequence Number: 21482968
• Product Code: DRC
• UDI-Device Identifier: 05414734205092
• UDI-Public: 05414734205092
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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 Model Number: 407200
• Device Catalogue Number: 407200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male