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

Catalog Number SGC0704

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/28/2022

Event Type  Injury  

Event Description

Patient id (b)(4).This is filed for access site bleeding.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.Patient anatomy included a rotated heart, mitral annular calcification, thickened leaflets, bi-leaflet prolapse, thick and dense chords in the ventricle and a deep scallop between posterior 1/posterior 2.Visualization was difficult due to shadowing and the rotated heart.The clip delivery system (cds) was advanced into the patient anatomy and the anterior leaflet became caught on the grippers.Trouble shooting was performed; however, the clip (xtw) was unable to be freed.Additional troubleshooting was not performed, as the physician did not want to get the clip caught in the chordae.The clip was implanted at the same location where the anterior leaflet was caught.It was suspected that there was a small chordal tear and a new flail.A second clip (xt) was then implanted and the mr was reduced to grade 2-3+.Post procedure, minor bleeding was noted at the vessel access site.Manual pressure was applied, as well as a sand bag.Additionally, the patient experienced hypotension post procedure and a fluid bolus was administered.One day post procedure, the patient experienced supraventricular tachycardia (svt) and fever.No intervention was performed as treatment of the svt, but tylenol as administered for the fever.No infection was noted.The hypotension resolved on (b)(6) 2022.The svt and fever resolved on (b)(6) 2022.On (b)(6) 2022, an epinephrine/lidocaine subcutaneous injection was administered.The bleeding resolved on (b)(6) 2022.No additional information was provided.

Manufacturer Narrative

The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional device referenced is filed under a separate medwatch report number.

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 reported patient effect of hemorrhage, as listed in the electronic g4 mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The investigation was unable to determine a cause for the reported hemorrhage.The reported unexpected medical interventions and medication required were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.

• 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: 13908532
• MDR Text Key: 289021212
• Report Number: 2024168-2022-03176
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2022
• Device Catalogue Number: SGC0704
• Device Lot Number: 11004R101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White