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

Catalog Number SGC0702

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/10/2022

Event Type  Injury  

Event Description

This is filed to report a tear in the septum.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+ with elastic septum, and rotated heart.The patient was presented with a dilated left atrium due to atrial fibrillation.The transseptal puncture was noted to be difficult due to rotated heart.The steerable guide catheter (sgc) was advanced with no reported issue.The clip was advanced to the mitral valve; however, it was not possible to grasp both leaflets due to suboptimal transseptal puncture.After two hours of procedure, a tear of the septum was noticed.It was not clear what caused the tear in the septum.It was decided to abort the procedure with mr remained at grade 4+.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.Based on available information, the cause of the reported unspecified tissue injury associated with the septal tear was due to procedural circumstances during transseptal puncture in conjunction with challenging patient anatomy (rotated heart, an enormous left atrium, a very elastic septum, and a difficult transseptal site).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.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced in event is filed under separate medwatch report number.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15914864
• MDR Text Key: 304792166
• Report Number: 2135147-2022-02329
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 12/05/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 20628R250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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: MITRACLIP
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Hispanic
• Patient Race: White