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

Catalog Number SGC0702

Device Problem Difficult to Advance (2920)

Patient Problem Perforation (2001)

Event Date 03/24/2022

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.

Event Description

This is filed to report atrial perforation and medical intervention.It was reported that this was a second mitraclip procedure to treat recurrent mitral regurgitation (mr) grade of 3 due to disease of progression.A steerable guide catheter (sgc) was inserted; however, it was not possible to advance the sgc upwards to the right atrium (ra) due to anatomical challenges.Then thrombus was observed at the tip of the wire in the left atrium.Aspirations were performed to remove the thrombus.But then a second thrombus was observed on a non-abbott catheter in the right atrium.The wire in the left atrium was retracted into the sgc, and both the sgc and wire were removed from the patient.The thrombus was removed with the guide.The physician stated the thrombus was not related to the sgc.The sgc was flushed with heparin saline.Then the procedure continued with the same sgc, and the sgc was able to be re-advanced to the mitral valve without issue.Two clips were successfully deployed.Two clips were implanted, reducing mr <1.After the procedure ended, the atrial septal defect was closed with an occluder.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 revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.A failure analysis of the complaint device could not be performed because the product was not returned for analysis.Based on the information reviewed, the reported difficult to advance was due to patient morphology/pathology as it was reported that the steerable guide catheter (sgc) was inserted; however, it was not possible to advance the sgc upwards to the right atrium (ra) due to anatomical challenges.The perforation (atrial septal defect) appears to be due to the difficulty advancing the device.The reported patient effect of perforation, as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was result of case-specific circumstance as the atrial septal defect was closed with an occluder.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

N/a.

• 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: 14106233
• MDR Text Key: 289224988
• Report Number: 2024168-2022-04014
• 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: 06/13/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 11014R123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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: 3 IMPLANTED MITRACLIPS
• Patient Outcome(s): Required Intervention