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

Catalog Number SGC0302

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the steerable guiding catheter (sgc) was returned and investigated.A torn hemostasis valve was observed during returned device analysis.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and a definitive cause for the tear in the hemostasis valve could not be determined.It is likely that while removing the clip delivery system (cds), damage may have occurred resulting in the formation of the tear; however, this cannot be determined.Based on the information reported, there is no indication of a product quality issue with respect to manufacture, design or labeling.The clip delivery system is filed under mfr report #2024168-2016-09157.

Event Description

This is filed to report that returned device analysis found that the hemostasis valve of the steerable guiding catheter (sgc) was torn, and if were to reoccur, has the potential to cause or contribute to patient injury.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.There was a large jet located along the a2-p2 and a1-p1 scallop.The clip delivery system (cds) was advanced to the leaflets and the mr was reduced to 3+ with grasping.Deployment steps were started, but after the gripper line was retracted a few millimeters, it could not be properly removed.It was confirmed that the gripper line moved freely during the gripper line removability test.Troubleshooting maneuvers were performed without success.The cds was removed, leaving the gripper line in place.After removing the cds, the two ends of the gripper line were visible outside the hemostatic valve of the steerable guiding catheter (sgc).Another attempt was made to remove the gripper line, but was unsuccessful.The sgc was then removed, leaving the gripper line in place attached to the deployed clip.A new sgc was advanced and a second clip was deployed lateral to the first clip, reducing the mr to 1-2.The patient was confirmed to be stable post procedure.The sgc was returned, and it was found that the hemostasis valve was torn.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
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6274829
• MDR Text Key: 65907607
• Report Number: 2024168-2017-00660
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216831
• UDI-Public: (01)08717648216831(17)170909(10)60908U117
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2017
• Device Catalogue Number: SGC0302
• Device Lot Number: 60908U117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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