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 Hematoma (1884); Perforation of Vessels (2135)

Event Date 04/19/2022

Event Type  Injury  

Event Description

This is being filed to report the perforation and hematoma requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was implanted without issue, reducing mr to 2.The clip delivery system (cds) and steerable guide catheter (sgc) were removed together.Manual compression was used to close the venous access.Despite a long and effective compression, a hematoma at the groin puncture point was noted one hour after the procedure.Additional compression was done to avoid hematoma expansion.The patient was stable and the bleeding was solved without any significant consequence.Per the physician, the sgc may have caused a small artery injury however this could not be confirmed.There was no clinically significant delay in the procedure and no adverse patient sequela.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.Based on the available information, the cause of the reported perforation of vessel is due to procedural conditions.The reported hematoma appears to be a cascading effect of the reported perforation of vessel.The reported effect of perforation of vessel and hematoma are listed in the mitraclip instructions for use (ifu) and are known possible complications associated with mitraclip procedures.There is no indication of a product quality 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: 14285885
• MDR Text Key: 290771499
• Report Number: 2024168-2022-04846
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/10/2022

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: 09/22/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10923R157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention