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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The two clip delivery system (cds) referenced are filed under separate medwatch report numbers.

Event Description

This is filed to report the loss of fluid column during device preparation.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4+.During device preparation of the steerable guide catheter (sgc), there was loss of fluid column as soon as the dilator was inserted into the sgc.There was no patient involvement, and it was exchanged for a new sgc.The procedure began and one clip delivery system (cds 10816r117) was advanced and placed medially on the mitral valve.During deployment, after the clip was released from the cds, it opened to 25 degrees.However, the clip remained stable on the leaflets and the mr was reduced to a grade of 2+.A second cds (11014r259) was advanced to the mitral valve, and it was noted that there was shadowing due to the cds.While in the ventricle, the clip got caught in the chords because there was not enough height in the left atrium which made it hard to navigate.Standard troubleshooting was performed to maneuver the device back into the left atrium.However, it is believed to have caused a leaflet perforation.The physician proceeded with implanting the clip and it was deployed medially on a2/p2.After the clip detached from the cds it was noted to have opened to 20 degrees, but the clip remained stable on both leaflets and the procedure was complete.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

The returned device analysis did not confirm the reported leak.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the cause of the reported leak could not be determined.There is no indication of a product quality 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: 14496459
• MDR Text Key: 292608751
• Report Number: 2024168-2022-05599
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: N/A
• Device Catalogue Number: SGC0701
• Device Lot Number: 11109R328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• 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