MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR

Catalog Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001. The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no similar incidents reported from this lot. All available information was investigated and a definitive cause for the reported sgc leak (loss of fluid column during sgc preparation) could not be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling. The clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is being filed to report leak. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. A steerable guide catheter (sgc) was being prepped; however, loss of fluid column was observed. The sgc was re-prepped with a new stopcock, but there was still loss of fluid column. The sgc was not used in the patient, and the procedure continued with a new sgc. The first clip was successfully deployed. Then a second clip delivery system (cds) was advanced to the mitral valve; however, the clip became caught with the chordae during placement. Troubleshooting was performed, and the clip was freed. Then a chordal rupture was observed. The cds was retracted back, and the clip was re-positioned to be placed lateral to the first clip and the clip was deployed. The chordal rupture was left untreated two clips were implanted, reducing mr to 3. The patient is stable. There was no clinically significant delay in the procedure. No additional information was provided.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• 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: 9203069
• MDR Text Key: 173552375
• Report Number: 2024168-2019-12693
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/20/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 81220U149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial