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

Catalog Number SGC0702

Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)

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

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The second steerable guide catheter is filed under a separate medwatch report number.

Event Description

This will be filed to report during insertion of the steerable guide catheter (sgc), the sgc was not able to advance due to vessel tortuosity.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr).During insertion of the steerable guide catheter (sgc); the sgc was not able to advance due to vessel tortuosity.When the sgc was retracted, the soft tip was noted to be squashed [smashed].A dilator was used to be able to the new sgc up to the vena cava.In addition, a thrombus was noted on the right side of the septum before crossing the sgc.The thrombus was aspirated before crossing the sgc.The procedure was completed successfully with the new sgc.One clip was implanted, reducing mr to 1-2.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported deformation due to compressive stress on the steerable guide catheter (sgc) shaft was confirmed via returned device analysis.In addition, the reported difficult to insert in the anatomy could not be replicated in the testing environment as it is related to the patient anatomy/procedural operational circumstances.Furthermore, the reported deformation due to the bend on the sgc soft tip was not confirmed for the returned device analysis.A review of the lot history identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.Based on all available information and the returned device analysis, the reported difficult to insert appears to be due to patient anatomy.Additionally, the reported bend on the curve of the shaft was a cascading effect of the reported difficult to insert.Lastly, the reported bent on the soft tip could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 12605394
• MDR Text Key: 276657164
• Report Number: 2024168-2021-09051
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10115U118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2021
• 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