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

Model Number SGC0701

Device Problems Leak/Splash (1354); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.The evaluation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional steerable guide catheter referenced is filed under a separate medwatch report number.Na.

Event Description

This is filed to report a leak.It was reported that this was a mitraclip procedure treat mixed mitral regurgitation (mr) with a grade of 4.The first steerable guide catheter (sgc 10105u151) was advanced to the mitral valve; however, resistance was felt when advancing the clip introducer (ci) of the clip delivery system (cds 10108u140) into the sgc.The ci was removed.Then after the sgc was removed from the patient, loss of fluid column was observed.Therefore, the procedure continued with a new sgc (01221u152).However, resistance was also felt when advancing the same ci into the second sgc.When the sgc was removed from the patient, loss of fluid column was also observed with the second guide.It was noted that the ci became bent and no fluid or air went into the patient.The procedure was successfully completed with a new sgc and cds.One clip was implanted, reducing mr to less than 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Thhttps://emdr.Fda.Gov/emdr/forminbox/is is filed to report a leak.It was reported that this was a mitraclip procedure treat mixed mitral regurgitation (mr) with a grade of 4.The first steerable guide catheter (sgc 10105u151) was advanced to the mitral valve; however, resistance was felt when advancing the clip introducer (ci) of the clip delivery system (cds 10108u140) into the sgc.The ci was removed.Then after the sgc was removed from the patient, loss of fluid column was observed.Therefore, the procedure continued with a new sgc (01221u152).However, resistance was also felt when advancing the same ci into the second sgc.When the sgc was removed from the patient, loss of fluid column was also observed with the second guide.It was noted that the ci became buckled and no fluid or air went into the patient.The procedure was successfully completed with a new sgc and cds.One clip was implanted, reducing mr to less than 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device return analysis revealed the clip introducer of the clip delivery system (cds 10108u140) was torn.

Manufacturer Narrative

All available information was investigated and the leak and resistance when inserting the clip introducer of the clip delivery system into the steerable guide catheter were confirmed via returned device 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 other complaints reported from this lot.The investigation determined the reported resistance during clip introducer insertion appears to be related to user technique.The leak was due to an observed torn silicone valve and the torn silicone valve appears to be a result of the resistance during insertion.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 11634826
• MDR Text Key: 246556432
• Report Number: 2024168-2021-02913
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01221U152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Age: 74 YR
• Patient Weight: 57