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

Model Number SGC0701

Device Problems Difficult to Advance (2920); Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 12/13/2021

Event Type  Injury  

Event Description

This is filed to report a guide catheter steering issue and vessel perforation.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted the inferior vena cava (ivc) was very tortuous.The steerable guide catheter (sgc) was inserted, but resistance was noted during advancement.Due to the tortuous ivc, it was observed on xray that the tip of the sgc went towards the patients left side and into the left renal vein.The sgc was straightened and advanced into the left atrium (la).The clip delivery system (cds) was inserted, but it was observed the patient blood pressure began to decline.While deploying the clip, medication was administered to treat the declining blood pressure.The physician suspected that the sgc perforated an offshoot vessel from the ivc.The physician quickly implanted the mitraclip, reducing mr to a grade of <1.The cds and sgc were removed, but contrast injection showed blood was pooling out of the left renal vein.For treatment, a percutaneous graft was placed.There was no clinically significant delay in the procedure.No additional information was provided.

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.

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 the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated and the reported difficult to advance the steerable guide catheter (sgc) resulting in guide steering issue appears to be related to patient anatomy (tortuous ivc).Perforation of vessels resulting in hemorrhage and hypotension appears to be related to the procedural circumstances of the guide steering issues associated with difficult sgc advancement.Hypotension, hemorrhage and perforation of vessels are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported medication required and unexpected medical intervention were 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
• 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: 13153204
• MDR Text Key: 283161843
• Report Number: 2024168-2022-00019
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10617R152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 55 KG