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

Model Number SGC0701

Device Problems Off-Label Use (1494); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).All available information was investigated, and the reported deformation due to compressive stress that was noted during the returned device analysis was confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints reported from this lot.All available information was investigated, and the reported deformation due to compressive stress appears to be due to procedural circumstances/user technique.The reported off-label use of the device was an outcome of use error as steerable guide catheter (sgc) was used to treat tricuspid regurgitation.It should be noted that per the steerable guide catheter instructions for use states that the steerable guide catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.The off-label use did not likely contribute to the reported issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional mitraclip device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report damaged steerable guide catheter (sgc) tip found during returned device analysis.It was reported that this was a mitraclip procedure to treat functional tricuspid regurgitation (tr) with a grade of 4.It was noted thin leaflets and imaging was difficult.The first clip was successfully deployed.A second clip delivery system (cds) was advanced to the tricuspid valve for off-label use; however, the clip was unable to grasp the leaflets due to the poor imaging.Therefore, a decision was made to remove the cds.But, when the cds was retracted back into the steerable guide catheter (sgc), one clip arm became caught on the sgc tip.Then a loud pop sound was heard, and the clip became detached from the cds, but the clip was still attached via the lock and gripper lines.The clip became inverted, but since the clip was no longer attached to the cds, the clip could not be closed.This resulted in a clinically significant delay in the procedure, and a surgical-down was planned.The clip was briefly stuck on tissue during removal from the vein, and the clip dislodged from the cds.Both the sgc and cds were removed, and the clip was ultimately removed through surgical down.The patient was sent to recovery.The lock line of the cds was examined outside the patient¿s body.The lock line was observed to be separated in two pieces.One clip was implanted, reducing mr to 2.The returned device analysis revealed the sgc soft tip was deformed.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: 10220347
• MDR Text Key: 197576540
• Report Number: 2024168-2020-05460
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00227U136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• 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 Age: 53 YR
• Patient Weight: 142