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

Model Number SGC0701

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Cardiac Enzyme Elevation (1838); Embolism/Embolus (4438); Unspecified Tissue Injury (4559)

Event Date 01/26/2021

Event Type  Injury  

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 the reported event.A review of lot-specific similar complaints revealed no indication of a lot-specific product quality issue.The reported patient effects of tissue damage, cardiac enzyme elevation, and embolism as listed in the instructions for use, mitraclip system gen 4, u.S.(ifu) are known complications associated with mitraclip procedures.Based on available information, the reported difficult or delayed positioning (anatomy) appears to be due to the thick septum (challenging patient anatomy).A cause for the reported patient effects of tissue damage and cardiac enzyme elevation could not be determined.The reported embolism appears to be a cascading effect of the tissue damage.The additional therapy/non-surgical treatment was the result of case-specific circumstances.There is no indication of product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report tissue damage.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with an mr grade of 4.When crossing the septum with the steerable guiding catheter (sgc), resistance was felt due to the thick septum.After the sgc crossed the septum, the dilator and guide wire were retracted; the patient had st elevation.It was suspected tissue from the septum potentially dislodged causing a 95% occlusion in the artery.Stenting was performed for treatment, and the mitraclip procedure was aborted.No clips were implanted.Mr remains at 4.The patient recovered and was reported to be doing well.Another mitraclip procedure will be discussed for a future date.The physician is not exactly sure of the actual cause for st elevation and occlusion as the patient has a history of arterial occlusion and a pre-existing graft that has been stented a few times.However, the physician feels a suspected tissue dislodgement from the septum could be the cause.No additional information was provided.

• 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: 11341211
• MDR Text Key: 232323486
• Report Number: 2024168-2021-01284
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00710U157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• 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