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

Model Number SGC0701

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Failure to Advance (2524); Unintended Movement (3026)

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

Event Date 11/28/2022

Event Type  malfunction  

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, the cause of the reported difficult or delayed positioning, the reported unintended movement associated with the sgc withdrawal into the right atrium, and the reported failure to advance across the septum were due to procedural circumstances of transseptal puncture in conjunction with challenging patient anatomy (severe scoliosis).The cause of the reported difficult to remove (entanglement) appears to be due to procedural circumstances during clip removal.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The mitraclip device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report the unintended movement of the device loosing access to the septum and the device entanglement during removal.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4.The patient presented with severe scoliosis so the transseptal and steerable guide catheter (sgc) introduction were very challenging.A xtw clip was advanced in the patient and positioned towards the valve.After adding 1/2 turn of + knob due to an aorta hugging trajectory and 1/2 turn of m knob it was apparent that nothing was improving the trajectory to the valve.At this point the sgc lost access across the septum and was now in the right atrium.The sgc was unable to be pushed back across the septum, so the clip was able to be steered back to the sgc.However, the clip became caught briefly on the sgc during removal.There was no damage to the sgc and a replacement xtw clip was used to complete the procedure, reducing mr to 1-2.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• 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: 16017041
• MDR Text Key: 308349395
• Report Number: 2135147-2022-02651
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20502R119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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: 1 MITRACLIP.
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White