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 Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Ischemia (1942)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.A review of the complaint history identified no other incidents reported from this lot.The reported patient effect of air emboli, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported slippage of the sgc, device operates differently than expected, appears to be a result of user technique/procedural conditions.The reported leak/air ingress appears to be a secondary effect of the device slippage.The reported patient effect of air embolism appears to be a result of procedural conditions, while the reported ecg changes and ischemia were symptoms/cascading effects of the air embolism.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.

Event Description

This is filed to report the suspected air embolism and air in the device.It was reported that this was a mitraclip procedure to treat grade 4 mixed etiology mitral regurgitation (mr).As the dilator was being retracted out of the steerable guide catheter (sgc), the sgc slipped back into the right atrium.Air was noted in the sgc hemostatic valve and was aspirated.A change in the electrocardiogram (ecg) was noted and an air embolism was suspected, but not found.The ecg returned to normal after a few seconds.The procedure continued with successful implantation of two mitraclips, reducing mr to trace.Post procedure, the patient was noted to be stable.There was no additional information 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: 6974422
• MDR Text Key: 90126685
• Report Number: 2024168-2017-08425
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70511U110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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
• Patient Outcome(s): Required Intervention