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

Catalog Number SGC0705

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/02/2022

Event Type  Injury  

Event Description

This is filed to report septum tear.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.It was noted leaflet restriction and prolapse in anterior and posterior.Visualization was difficult due to imaging quality and equipment.A steerable guide catheter (sgc) crossed the septum and was advanced to the mitral valve with resistance, and then a ntw clip delivery system (cds 10717r117) was advanced to the mitral valve.However, the clip could not capture both leaflets.Therefore.The cds was removed with the clip attached.The procedure continued with a longer clip.An xtw clip (10907r164) was successfully deployed in the a2/p2.However, capturing both leaflets was difficult.A second xtw clip (10907r140) was attempted to be implanted medial to the first clip to further reduce mr, but the septum was floppy and tore, causing an aorta hugger.Troubleshooting was performed but the clip was not coaxial and it was not possible to capture both leaflets.A decision was made to remove the clip.However, during removal, the clip became stuck in the sgc's tip and the clip opened.The clip was then pushed to the left atrium and re-closed.The clip was pulled into the inferior vena cava without inserting the clip into the sgc because the clip would open every time.However, the clip prematurely deployed from the cds into inferior vena cava.The clip was no longer attached to the gripper lines, and therefore the clip had to be snared and was removed.The torn septum was left untreated and the patient is stable.One clip was implanted, reducing mr to 1.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device is filed under separate medwatch report number.

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 similar incidents reported from this lot.Based on available information, a cause of the reported resistance could not be determined.The reported tissue injury appears to be due to challenging anatomy.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.There is no indication of a product quality 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: 13873385
• MDR Text Key: 288309165
• Report Number: 2024168-2022-03045
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10621R133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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: 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 95 KG