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

Catalog Number SGC0702

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/05/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The first clip referenced is filed under a separate medwatch report number.

Event Description

This is being filed to report thrombus.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3+.After the transseptal puncture and when the steerable guide catheter (sgc) was advanced through the septum a mass was noted to be floating right at the puncture point next to the sgc.The dilator was removed from the sgc and the mass was aspirated, while bridging medication (heparin) was administered.The mass was secured in a 50cl syringe and appeared to be connective tissue of approx.1 cm in length.The sgc then was prepared again completely and reinserted into the left atrium with the dilator.Then, the clip delivery system (cds) was advanced to the mitral valve and when checking the grippers individually, the gripper with tactile did not come down.Troubleshooting was performed, gripper levers were retracted and advanced multiple times but was unsuccessful.The cds was then removed and a new cds was used to complete the procedure successfully.One clip was implanted, reducing mr to 1.There was no adverse patient sequela and no clinically significant delay in the procedure.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.Based on available information, a cause for the reported tissue injury could not be determined.However, the reported patient effect of tissue injury is listed in the instruction for use (ifu) as a known possible complications associated with mitraclip procedures.The reported 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: 12704006
• MDR Text Key: 278555599
• Report Number: 2024168-2021-09648
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 12/02/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10429R304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention