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

Catalog Number SGC0705

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Tachycardia (2095)

Event Date 03/09/2022

Event Type  Injury  

Event Description

This is filed to report hematoma, tachycardia, hypotension, delay, medical intervention, and prolonged hospitalization.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3+.The steerable guide catheter (sgc) was advanced to the septum without issue.However, after the clip delivery system (cds) was inserted and the straddle position was reached, the patient's blood pressure began to slowly drop and the lower abdomen became swollen.Hematoma was in the bladder.Contrast was performed from the sheath of the left inguinal region.Bleeding was confirmed in the abdominal cavity, but the bleeding point was not confirmed.This caused a clinically significant delay in the procedure.Since blood pressure was at 60-70 range, a decision was made to remove the sgc and cds from the patient and test for the bleeding point.Medication was administered and then the blood pressure dropped to 50 and the heart rate was at 130.A blood transfusion was performed with administration of blood products.Then an intra-aortic balloon pump (iabp) was inserted from the left inguinal region and a detailed computed tomography(ct) was performed.The bleeding site still remained unknown; however, the physician stated the sgc may have caused the clinical outcomes.The patient's general condition improved; and therefore the iabp was removed.The mitraclip procedure was aborted and no clips were implanted, mr is 3+.The patient remained hospitalized longer.The next day, a contrast-enhanced catheter was performed, but the bleeding point was still unknown.The patient will be scheduled for a follow-up.No other 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 evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for the reported hematoma and hemorrhage resulting in hypotension, inflammation and tachycardia cannot be determined.Hematoma, hypotension, inflammation, hemorrhage and tachycardia are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported medication required, unexpected medical interventions, delay to treatment/therapy and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

N/a.

• 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: 13965585
• MDR Text Key: 288289953
• Report Number: 2024168-2022-03396
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 11001R148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 45 KG