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

Model Number SGC0701

Device Problems Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The clip delivery system is filed under mfr report ref # 2024168-2020-07951-00.

Event Description

This is filed for torn silicone valve.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.It was noted that there was some resistance, more than with other mitraclip devices, when advancing the clip delivery system (cds) out of the steerable guide catheter (sgc).It was thought that this was perhaps due to the g4 device, as this resistance was noted with both of the clip delivery systems used.There were no adverse patient effects, or clinically significant delay.No additional information was provided.Returned device inspection noted that the silicone valve was torn.

Manufacturer Narrative

All information was investigated and the reported difficult clip delivery system (cds) advancement through the steerable guide catheter was not confirmed.Additionally, the silicone valve was observed to be torn.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 similar complaints from the lot.All information was investigated and a cause for the difficult cds advancement cannot be determined.As the difficulty advancing was reported near the distal end of the device and not during insertion, this was likely due to procedural circumstances and/or the way the device was packaged and shipped (post-procedural handling) and not indicative of a product issue.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10744289
• MDR Text Key: 213502360
• Report Number: 2024168-2020-08950
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00318U142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 128