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

Model Number SGC0301

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

The device was received and investigated. The reported tear and leak was not confirmed as no leak or tear was observed. A review of the lot history record revealed no manufacturing issued to the reported lot. Additionally, a review of the complaint history identified no other incidents reported from this lot. All available information was investigated and a definitive cause for the reported leak and tear cloud not be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the steerable guide catheter (sgc) leak. It was reported this was a mitraclip procedure to treat mixed mitral regurgitation. When inserting the steerable guide catheter (sgc), after the dilator and guidewire were pulled back air entered the sgc, requiring additional aspiration. A tear was noted in the sgc hemostatic valve. Air did not enter the patient. The device was replaced with a new sgc. There were no adverse patient effects and no clinically significant delay in the procedure. A new sgc was used to continue 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: 9782214
• MDR Text Key: 183095628
• Report Number: 2024168-2020-01969
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/15/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 91115U218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/03/2020 Patient Sequence Number: 1