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

Catalog Number SGC0302

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the steerable guide catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The two clip delivery systems (cds 70301u147, 70301u149) referenced in describe event or problem are filed under separate medwatch report numbers.

Event Description

This is filed to report the suspected leak in the steerable guide catheter (sgc).It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The imaging quality was poor.The steerable guide catheter (sgc 70320u135) and the first clip delivery system (cds 70301u147) were advanced.Leaflet insertion was confirmed and the clip was deployed; however, one minute after deployment, the clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).During removal of the cds, the septal access was lost.A leak was suspected on hemostatic valve of sgc due to air noted in the valve; therefore, aspiration was performed and the sgc was removed and replaced.The second cds (70301u149) was advanced for treatment of the slda clip.Grasping was difficult due to the restricted leaflet, and there were several interactions with the chordae.Troubleshooting was performed and the clip was freed from the chordae, but the clip then became tangled with the slda clip.The clip was freed from the implanted clip successfully; however, the patient became hypotensive for a few minutes and was treated with fluids and medication.The cds was removed with the clip and the procedure was discontinued.The mr remained at 4.It was confirmed that the patient is hemodynamically stable and extubated with a good outcome.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and a definitive cause for the reported leak and device slippage could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 6669856
• MDR Text Key: 78477700
• Report Number: 2024168-2017-05388
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70320U135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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
• Treatment: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 48