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

Catalog Number SGC0705

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report tissue damage and damage to the steerable guide catheter soft tip.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 3-4.When inserting the steerable guide catheter (sgc) into the right femoral vein, strong torque was applied because the sgc was failing to enter the anatomy.When the strong torque was applied, a "cutting tissue" sound was heard.There was no abnormal bleeding observed at the access site, so the procedure continued.The sgc then could not advance through the septum, therefore, the sgc was removed from the patient.Tissue damage at the access site was noted and the soft tip was observed to be torn.A replacement device was used to complete the procedure and mr was reduced to grade 2.No additional information was provided.

Manufacturer Narrative

The returned device analysis did not confirm the reported soft tip tear (material split, cut or torn); however the soft tip was observed to be deformed (stretched).The reported difficult to insert-anatomy and failure to advance-septum could not be replicated in a testing environment.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and while the reported soft tip tear was due to user¿s perception of the deformation of the soft tip, a cause for the reported difficult to insert the sgc into the anatomy and failure to advance the sgc through the septum resulting in the observed deformed/stretched soft tip (deformation due to compressive stress) cannot be determined.Unspecified tissue injury appears to be related to the procedural conditions associated with difficult sgc insertion and failure to advance and the user technique of attempting to insert and advance the sgc.Tissue damage is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.Serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER (CE)
• 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: 16954368
• MDR Text Key: 315481579
• Report Number: 2135147-2023-02188
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2023
• Device Catalogue Number: SGC0705
• Device Lot Number: 21019R1027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 61 KG