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

Model Number SGC0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Perforation (2511)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the available information, a cause for the reported atrial perforation could not be determined.The reported patient effect of atrial perforation is listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures.The reported additional therapy/non-surgical treatment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

Event Description

This is filed to report atrial perforation.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (fmr) with a grade of 4.Noted a very small valve area less than 3 and a balloon pump was used to help flow.There was a high mean gradient of 10 and a max gradient of 20.Ultimately it was decided not to implant the clip so it was removed still attached to the cds.The mean pressure gradient returned to baseline.However, after the steerable guide catheter (sgc) was removed, a significant left atrial pressure was observed.To alleviate the left atrial pressure burden, the physician decided to implant an atrial septal defect (asd) device, but in order to maintain the shunt, the physician removed the polyester inserts from the asd device to maintain the asd.The physician decided to implant an asd closure device.The closure device was implanted successfully and transesophageal echography demonstrated significant intra-device shunting.No clips were implanted and mr remained grade 4.There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.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
• 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: 10868633
• MDR Text Key: 217148062
• Report Number: 2024168-2020-09731
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00731U134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 72 YR