MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Catalog Number SGC0705

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 01/25/2022

Event Type  Injury  

Event Description

Patient id: (b)(6).This is filed for pericardial effusion, requiring intervention.It was reported that this was a mitraclip procedure, performed to treat functional mitral regurgitation (mr) of grade 4.The septal puncture was performed and the steerable guide catheter (sgc) was inserted without issue.The clip delivery system (cds) was advanced and positioned.Grasping attempts were made and it was noted that the patient¿s blood pressure decreased.A pericardial effusion was noted.At this time, it was noted that good leaflet insertion was noted and the clip was implanted.Pericardiocentesis was performed.The pericardial fluid continued to drain; therefore, the decision was made to place an atrial septal occluder.After the occluder was placed, the pericardial effusion resolved with time and the blood pressure stabilized.The procedure was completed, with implant of one clip and the mr reduced to grade 1.No additional information was provided.

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Patient id: (b)(6).This is filed for pericardial effusion, requiring intervention.It was reported that this was a mitraclip procedure, performed to treat functional mitral regurgitation (mr) of grade 4.The septal puncture was performed and the steerable guide catheter (sgc) was inserted without issue.The clip delivery system (cds) was advanced and positioned.Grasping attempts were made and it was noted that the patient¿s blood pressure decreased.A pericardial effusion was noted.At this time, it was noted that good leaflet insertion was noted and the clip was implanted.Pericardiocentesis was performed.The pericardial fluid continued to drain; therefore, the decision was made to place an atrial septal occluder.After the occluder was placed, the pericardial effusion resolved with time and the blood pressure stabilized.The procedure was completed, with implant of one clip and the mr reduced to grade 1.No additional information was provided.

Event Description

Subsequent to the initial report, additional information was received.Cardiac tamponade occurred with the pericardial effusion.Pericardiocentesis was performed, and then an atrial septal occluder was placed.The event resolved on 02/17/2022.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of perforation, cardiac tamponade, pericardial effusion, and hypotension as listed in the instructions for use (ifu), are known possible complications associated with mitraclip procedures.Based on available information, a cause for the reported perforation, pericardial effusion and cardiac tamponade could not be determined.The reported hypotension is cascading event of reported pericardial effusion and cardiac tamponade.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13552226
• MDR Text Key: 285822617
• Report Number: 2024168-2022-01663
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10805R249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 67 KG