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

Model Number SGC0701

Device Problem Failure to Advance (2524)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 02/18/2022

Event Type  Injury  

Event Description

This is filed to report the vein injury.It was reported this was a mitraclip procedure performed to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) did not advance through the stenosed vein.The sgc was removed, and a balloon was used to treat the stenosis and re-open the vein.The decision was made to discontinue the procedure because the physician did not want to administer more heparin to the patient.A tear in the vein was observed.It is unknown if a previous catheter or the sgc caused the tear in the vein.Balloon angioplasty was performed to treat the vein injury.There was no adverse patient sequela and no clinically significant delay.No clips were implanted, mr remains at 4.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 that would have contributed to this event.Additionally, a review of the complaint history identified no similar incident reported from this lot.Based on the available information the cause of the reported failure to advance is due to patient anatomy.The reported perforation of the vessel appears to be due to procedural conditions.Vessel perforation is listed in the mitraclip g4 system instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of product issue with respect to manufacture, design, or labeling.Code 2001 removed.

• 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: 13727375
• MDR Text Key: 287531662
• Report Number: 2024168-2022-02514
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10819R140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 79 KG