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

Model Number SGC0701

Device Problems Crack (1135); Leak/Splash (1354); Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

This is filed to report the steerable guide catheter (sgc) leak.It was reported that this was a mitraclip procedure performed to treat tricuspid regurgitation (tr) with a grade of 4.The clip was advanced to the mitral valve and was deployed.However, when attempting to attach a syringe to aspirate the steerable guide catheter, while removing the mitraclip delivery system (cds), as per the instructions for use (ifu), the sgc flush port cracked and leaked.Additional aspiration was required.Air did not enter the patient.The physician stated he put too much torque on the syringe resulting in the damage.The device was replaced, and the procedure continued without further issue.A total of three clips were implanted, reducing tr to <1.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no lot-specific product issue from this lot.Based on available information, the reported crack on flush port appears to be due to user technique.The reported leak was cascading event of the reported crack.The reported off label use was associated with the use of the mitraclip device on the tricuspid valve.The reported unexpected medical intervention was a result 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: 14105626
• MDR Text Key: 289220108
• Report Number: 2024168-2022-04006
• 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: 06/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 11104R353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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
• Treatment: IMPLANTED MITRACLIP(X1)
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 76 KG