MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Atrial Perforation (2511)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

The reported device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedure.All available information was investigated and the cause for reported tear on the steerable guide catheter (sgc) soft tip could not be determined.Perforation appears to be related to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional mitraclip device referenced is being filed under a separate medwatch report.

Event Description

This is filed to report soft tip damage and atrial perforation.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3.An xtr clip delivery system (cds) (91113u102) was advanced and grasping was successfully performed, reducing mr.During deployment of the clip, the gripper line was pulled, but after retracting roughly 1.3m, the gripper line became stuck.In an attempt to remove the gripper line, the physician decided to remove the cds.However, after removal of the cds, the gripper line was still unable to be removed.Therefore, the physician decided to remove the steerable guide catheter (sgc) (91022u160) and insert a multipurpose catheter to try and remove the gripper line.It was noted that upon removal of the sgc, a slight slit was visible on the soft tip.When attempting to remove the gripper line, addition force was applied, which caused mr to increase.The gripper line was unable to removed, so to reduce mr, an additional clip was implanted while using a separate sgc.The gripper line was left in the patient and a closure the device was used to close the atrial septal defect.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• 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: 9818642
• MDR Text Key: 184445750
• Report Number: 2024168-2020-02264
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2020

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: 10/21/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 91022U160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• 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