MAUDE Adverse Event Report: ABBOTT VASCULAR SGC07; CATHETER, STEERABLE

Model Number SGC0701

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated, and the reported material separation (flush port break) appears to be related to user related circumstances as the user¿s hand hit the steerable guide catheter (sgc) side flush port and the side flush port broke off from the device.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the flush port break.It was reported that this was a mitraclip procedure, performed to treat grade 4+ mixed mitral regurgitation (mr).The steerable guide catheter (sgc) was advanced.When inserting the mitraclip delivery system (cds) into the sgc, the users hand inadvertently hit the sgc side flush port and the side flush port broke off from the device.The devices were removed, a new sgc was used and two clips were implanted, reducing mr to 3+.There was no reported adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: SGC07
• 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: 10627413
• MDR Text Key: 209809339
• Report Number: 2024168-2020-08255
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00623U535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• 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
• Treatment: MITRACLIP DELIVERY SYSTEM
• Patient Age: 72 YR