MAUDE Adverse Event Report: ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER (CE); CATHETER, STEERABLE

Catalog Number SGC0705

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

Patient Problems Paresis (1998); Unspecified Tissue Injury (4559)

Event Date 07/14/2023

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 this event.Based on available information, the reported unspecified tissue injury associated with the assumption that the deposit was from a tissue injury appears to be due to the device interacting with patient pathology/ morphology.The reported paresis associated with the right upper extremity paralysis appears to be due to pre-existing atrial fibrillation.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was 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 a tissue injury.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade of 3+.When the steerable guide catheter (sgc) was advanced to the left atrium, deposits were confirmed on the sgc at the level where the dilator touched the atrial septum.Once the sgc is removed from the anatomy, it is confirmed that there are no deposits.The sgc was flushed and advanced to the right atrium again.A stringy deposit was observed again.It is believed that the deposit is a tissue likely originated from the inferior vena cava.When attempting to remove the deposit, it disappeared.After confirming that there are no deposits or thrombus on the sgc, and that the activated clotting time (act) is close to 300 seconds, the procedure is continued.One clip was implanted a2/p2 with no reported issue, reducing mr to grade 1+.There was no clinically significant delay in the procedure and no adverse patient sequelae.At night, post-procedure, paralysis of the right upper extremity was observed.Magnetic resonance imaging (mri) was taken, showing a small infarction in the motor cortex.The physician¿s diagnosis was that it was thought to be related to atrial fibrillation.No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER (CE)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17461366
• MDR Text Key: 320473547
• Report Number: 2135147-2023-03432
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2024
• Device Catalogue Number: SGC0705
• Device Lot Number: 30419R2054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• 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): Other
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 42 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian