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

Catalog Number SGC0702

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

Patient Problem Perforation of Vessels (2135)

Event Date 02/14/2022

Event Type  Injury  

Event Description

This is being filed to report a perforation of vessel requiring intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The patient was noted to have tortuous femoral and iliac veins.Following the transseptal puncture, the steerable guide catheter (sgc) was introduced over the guidewire into the femoral vein.While advancing the sgc in the vasculature, resistance was noted.Fluoroscopy was performed and imaging showed that the tip of the sgc and guidewire were bent.The sgc and guidewire were removed and contrast was injected and revealed a perforation in the iliac vein.The mitraclip procedure was aborted with mr remaining 4.Manual compression of the perforation was performed and heparin was reversed with protamine.An endovascular occlusion balloon was inserted which successfully treated the perforation.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

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 the available information the cause of the reported failure to advance was patient anatomy.Additionally, the reported deformation and perforation are cascading effects of the reported failure to advance.The reported patient effect of perforation is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported unexpected medical interventions and medication were a result of case-specific circumstances.There is no indication of product issue with respect to manufacture, design, or labeling.H6: code 4012 was removed.

• 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: 13720787
• MDR Text Key: 286931881
• Report Number: 2024168-2022-02457
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/29/2022

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: 07/21/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10722R342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 04/15/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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: GUIDE WIRE
• Patient Outcome(s): Required Intervention