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

Catalog Number SGC0302

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 incidents reported from this lot.All the available information was investigated.The definitive cause for the reported leak could not be determined.The product quality problem appears to be related due to user technique/procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional device referenced is being filed under separate medwatch report.

Event Description

This is being filed to report leak and medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.A steerable guide catheter (sgc) was advanced to the mitral valve.Then the clip delivery system (cds) was inserted into the sgc; however, during advancement of the cds, air entered the sgc.The sgc was immediately removed from the stabilizer, positioned lower to ensure no air was inside, and additional aspirations were performed.It was confirmed there was no air in the sgc and air did not enter the patient.At that time, the cds was to be removed from the sgc; however, the clip became stuck in the clip introducer.It was suspected that the hemostasis valve of the sgc was damaged, but this could not be confirmed.Both the sgc and cds were removed from the patient.The procedure continued with a new cds and sgc.One clip was implanted, reducing mr to 1.There were no adverse patient effects and 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: 9203013
• MDR Text Key: 162841821
• Report Number: 2024168-2019-12692
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90627U125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• 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
• Patient Age: 87 YR
• Patient Weight: 53