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

Catalog Number SGC0705

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the vascular injury requiring intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.Upon insertion of the steerable guide catheter (sgc), resistance was noted after passing the inguinal region.The dilator was pulled back into the sgc lumen by about 5 mm, and the sgc was inserted after the dilator was pushed in.Fluoroscopic images confirmed the bending and slight resistance of the sgc; minus knob was applied however the tip was difficult to straighten due to the bending of the tip due to the anatomy.The sgc was advanced and the tip reached the left atrium (la).One clip was implanted, reducing mr to 1.When pulling back on the sgc, a vascular injury was noted.When the sgc was completely removed, the patients blood pressure dropped from 110 to 40.Medication was administered and ballooning was performed to stop the bleeding.Contrast showed leakage of blood from the common iliac vein, therefore a stent was implanted as treatment.After placement of the stent, the contrast results confirmed that complete hemostasis had not been achieved; therefore an additional stent was placed.Per the physician, the vascular injury was due to the step between the soft tip and the dilator.There was no clinically significant delay in the procedure and no adverse patient sequela.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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information the reported deformation of the tip and difficulty straightening the sgc appear to be due to challenging patient anatomy.The reported difficult sgc insertion appears to be due to procedural conditions.The reported perforation of the iliac vein appears to be a cascading event of the difficult sgc insertion.The reported hypotension appears to be a cascading event of the vein perforation.Additionally, perforation of vessels and hypotension are listed in the mitraclip instructions for use (ifu) as known possible complications associated with mitraclip procedures.The unexpected medical intervention and medication were the results of case-specific circumstances.There is no indication of 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: 13929570
• MDR Text Key: 288036820
• Report Number: 2024168-2022-03216
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10805R110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Female