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 Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

The device was discarded.Investigation is not yet completed.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report during the procedure, the patient developed a retroperitoneal bleed in the inferior vena cava (ivc).It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.The steerable guide catheter (sgc) was advanced and positioned.The clip delivery system (cds) was advanced to the mitral valve and when the clip was being aligned, the patient¿s blood pressure dropped.Upon investigation, it was noted that the patient developed a retroperitoneal bleed in the inferior vena cava (ivc).The sgc and cds were removed and the mitraclip procedure was stopped to treat the retroperitoneal bleed.Continual pressure on the abdomen was applied and blood transfusion was required.The patient was stabilized and remained hospitalized.There were no clips implanted, mr remained at 4.The mitraclip procedure was postponed for a later date.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.The investigation was unable to determine a cause for the reported hemorrhage.The hypotension was due to the hemorrhage.Hemorrhage and hypotension are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported unexpected medical interventions and hospitalization were results 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: 12737673
• MDR Text Key: 279576028
• Report Number: 2024168-2021-09845
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/07/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10511R127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 60 KG