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 Problem Embolism/Embolus (4438)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional device is filed under a separate medwatch report number.Na.

Event Description

This is filed to report embolism, intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (fmr) with a grade of 4.During preparation of the clip delivery system (cds), when the gripper was lowered, it appeared slightly distorted and was exposed slightly outside the clip arm when the clip was tightened.The gripper has a natural look and has an impression of coming out of the arm a little.The device was not used and a new cds was prepped for the procedure.When the steerable guide catheter (sgc) entered the left atrium, there appeared to be a blood clot.It was attempted to aspirate the clot but was unsuccessful.The physician commented that it may be septal tissue.The new clip was advanced to the mitral valve and implanted and mr reduced to 1-2.There were no reported adverse patient sequela and there was 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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.Based on this information, the reported embolism was related to procedural conditions.The reported patient effect of embolism as listed in the mitraclip nt system (g4) (jpn) instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case specific circumstances as the reported embolism was attempted to be aspirated.There is no indication of a product issue with respect to manufacture, design or labeling.D9: device return status updated to 'no'.

Event Description

It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (fmr) with a grade of 4.During preparation of the clip delivery system (cds), when the gripper was lowered, it appeared slightly distorted and was exposed slightly outside the clip arm when the clip was tightened.The gripper has a natural look and has an impression of coming out of the arm a little.The device was not used and a new cds was prepped for the procedure.When the steerable guide catheter (sgc) entered the left atrium, there appeared to be a blood clot.It was attempted to aspirate the clot but was unsuccessful.The physician commented that it may be septal tissue.The new clip was advanced to the mitral valve and implanted and mr reduced to 1-2.There were no reported adverse patient sequela and there was no clinically significant delay in the procedure.Subsequent to the initially filed report the following information was provided: the grippers were not able to lower or raise as intended during prep.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
• MDR Report Key: 11859987
• MDR Text Key: 261600724
• Report Number: 2024168-2021-04283
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10109U136
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 49