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

Model Number SGC0701

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

Patient Problem Perforation (2001)

Event Date 11/04/2021

Event Type  Injury  

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.The reported patient effect of perforation, as listed in the mitraclip g4 system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported perforation (atrial: percutaneous intervention) appears to be due to procedural conditions.The surgical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.The clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed to report the septal injury.It was reported this was a mitraclip procedure performed to treat degenerative mitral regurgitation (mr).The first clip was implanted, without issue.To further reduce mr a second clip was advanced; however, the clip got stuck in the lateral chords.When attempting to remove the mitraclip delivery system (cds), septal height was lost.The cds was eventually removed with the clip intact; however, it is possible a leaflet tear occurred due to the clip entanglement.A septal tear was observed caused by the steerable guide catheter.Mitral valve replacement was performed, and the septal tear was surgically repaired.The surgery went well, and the patient was fine after the surgery.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
• 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: 12849388
• MDR Text Key: 281577832
• Report Number: 2024168-2021-10664
• 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
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10726R111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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: IMPLANTED MITRACLIP(X1).
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 81 KG