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

Model Number SGC0701

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 08/20/2021

Event Type  Injury  

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 the reported issue.Based on the available information, a cause of the reported atrial perforation could not be determined.The cause of the reported hypotension could not be determined.The reported patient effect of atrial perforation and hypotension as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported hospitalization and required medication were a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report after the procedure an atrial septal dissection was noted.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.There was some difficulty during transseptal puncture but was achieved.The steerable guide catheter (sgc) was advanced without issue and placed in position.Two clips implanted successfully, reducing mr to 1+.The patient was stable.However, the next day the patient blood pressure dropped, and it was noted that an atrial septum dissection had occurred.There is a possibility that it could have occurred during transseptal puncture and the sgc could have worsened it.The physician commented that this was a rare entity.There was no treatment performed for the atrial septal dissection.The patient remained hospitalized for monitoring and medication was administered for the hypotension.The clips remained stable on both leaflets and mr remained at 1+.No additional information was provided.

• 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: 12527059
• MDR Text Key: 273152652
• Report Number: 2024168-2021-08555
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10514R144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• 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): Hospitalization; Required Intervention