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

Model Number SGC0701

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

The device was discarded and will not return for analysis.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is being conservatively filed for tissue injury, possibly device related.It was reported that on (b)(6) 2022, a mitraclip procedure was scheduled.The right femoral access was performed, and the transeptal catheter was advanced with difficulty.Following, the steerable guide catheter (sgc) was unable to advance through the very tortuous iliac artery.The device was removed without an issue reported.Once removed, the guide shaft appeared indented (deformed).There appeared to be some dye extravasation surrounding the tissue at the point of stenosis and where the guide was removed.No additional treatment was provided.The procedure was aborted.No clip was attempted.No additional information was provided regarding this issue.

Manufacturer Narrative

Medical device code 2017 applied for failure to follow instructions.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 unspecified tissue injury (no treatment) associated with the injury at the site the steerable guide catheter (sgc) could not advance beyond, and the reported deformation due to compressive stress (shaft) associated with the kinked shaft, were due to stress put on the device from the failure to advance.The reported failure to advance associated with the inability to advance the sgc past the iliac vein was due to challenging patient anatomy (very tortuous iliac vein).The reported improper or incorrect procedure or method (failure to follow steps / instructions) was associated with advancing the sgc dilator 20cm past the tip of the sgc.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.

• 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: 15759971
• MDR Text Key: 303330688
• Report Number: 2135147-2022-02003
• 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: 01/05/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20407R153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 78 KG