MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

Subsequent, to the initial 30-day medwatch report, it was reported that the steerable guide catheter (sgc) performed as intended. There was no steering issue or difficulty noted during removal of the sgc. This event has been reported; therefore, it will remain reportable. No additional information was provided.

Manufacturer Narrative

(b)(4). Subsequent, to the initial 30-day medwatch report, it was reported that the steerable guide catheter (sgc) performed as intended. There was no steering issue or difficulty noted during removal of the sgc. This event has been reported; therefore, it will remain reportable. No further investigation is required.

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the clip was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The clip delivery system referenced in is filed under a separate medwatch report number.

Event Description

This is filed to report the difficult removal. It was reported that on (b)(6) 2017, the patient, with functional mitral regurgitation (mr), underwent a mitraclip procedure. Patient anatomy included a large aorta and a small left atrium. The steerable guide catheter (sgc) was advanced into the patient anatomy without issue. Due to the patient anatomy, some visualization difficulties were noted. However, when the clip delivery system (cds) was advanced, a steering issue was noted. The cds was not properly aligned during insertion and when the m knob was applied, the device did not respond appropriately. It was decided to remove the cds in order to properly align, but during retraction, one of the clip arms became stuck between the sgc and the grippers. Troubleshooting maneuvers were performed in order to release the clip arm from the sgc, but troubleshooting was unsuccessful. The physician made the decision to retract the sgc with the clip remaining stuck on the sgc. This was performed slowly in order to not injure the patient. After removal, the decision was made to use a new sgc and a new cds. A new vessel access site was performed in the right femoral artery. The clip was implanted in the central portion of the anterior 2/posterior 2 (a2/p2) leaflet segment and the mr was reduced from grade 4+ to grade 1+. No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7173426
• MDR Text Key: 284202543
• Report Number: 2024168-2018-00170
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: SGC0302
• Device Lot Number: 70922U134
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 01/08/2018 Patient Sequence Number: 1

Treatment

CLIP DELIVERY SYSTEM