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

Catalog Number SGC0702

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 04/05/2022

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 filed to report suspected embolism, thrombus, low blood pressure, congestive heart failure and septal shunting requiring medication.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.Two clips were successfully implanted reducing mr to <1.All devices were reported to have functioned as intended.While closing the femoral puncture site, the patient decompensated and blood pressure dropped.The right side of the heart appeared to have increased pressure load as the septum was displaced to the left and, right to left septal shunting was observed.The patient was treated with a bolus of arterenol and stabilized.Right heart pressure improved and septal shunting returned to left to right again.In the physician's opinion, a small pulmonary embolism was suspected to have caused the noted events and the sgc may have loosened a thrombus already in the venous system.Following the procedure, the patient was noted to be alert, oriented, and stable.There was no clinically significant delay in the procedure and no adverse patient sequelae.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.Based on this information, a cause for the reported thrombosis and perforation could not be determined.The reported hypotension and heart failure are cascading events of reported perforation and thrombosis.The reported embolism is cascading event of reported thrombosis.The reported patient effects of thrombosis, perforation, hypotension, and heart failure as listed in the mitraclip instructions for use (ifu), as known possible complications associated with mitraclip procedures.The reported medication that was required 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
• 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: 14239145
• MDR Text Key: 290306477
• Report Number: 2024168-2022-04623
• 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: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10406R203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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: TWO IMPLANTED MITRACLIPS
• Patient Outcome(s): Required Intervention