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

Model Number SGC0701

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed for broken flush port.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) of grade 4+.The steerable guide catheter (sgc) was advanced and was noted to be mis-keyed.The device was removed; however, the flush port was inadvertently bumped, causing the flush port to snap off.Blood was noted to exit the device; however, the patient did not experience a blood loss and no air entered the patient anatomy.No intervention was performed.A second sgc was then prepared and used, and one clip was implanted.The mr was reduced from grade 4+ to grade 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

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 similar 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 flush port was inadvertently bumped, causing the flush port to snap off.There is no indication of a product issue with respect to manufacture, design or labeling.The clip delivery system mentioned in b5 is filed under mfr report number 2024168-2020-08989na.

Event Description

Subsequent to the initial mdr report, additional information was provided.It was reported that during the procedure, the clip delivery system (cds) and steerable guide catheter (sgc) were noted to be mis-keyed.The devices were pulled back to key correctly.The alignment markers were noted to be aligned during insertion and removal of the devices.When the devices were pulled back to re-align, the flush port was bumped, knocking it off.A second sgc was prepared and one clip was implanted.No additional information was provided.

• 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: 10714312
• MDR Text Key: 212479819
• Report Number: 2024168-2020-08814
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00709U111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1