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

Catalog Number SGC0302

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

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 reportedly discarded and is not returning.Investigation is not yet complete.A follow-up medwatch report will be submitted with all additional, relevant information.

Event Description

This report is filed as air entered the steerable guide catheter during use.It was reported that this was a mitraclip procedure treating functional mitral regurgitation grade 2-3.During clip delivery system (cds) insertion into steerable guide catheter (sgc), at approximately 2-3 cm and when the cds steerable sleeve meets the hemostatic valve of the clip introducer, air had entered the sgc.About half of the transparent guide chamber was filled with air.The operator was advanced the cds further into the sgc and aspirated air out of the sgc.The issue resolved and there was no more air noted in the sgc.No air had entered into the patient's anatomy.The procedure was continued with the same sgc and the mitraclip was successfully implanted, reducing the mr to <1.There was no clinically significant delay and there were no adverse patient effects.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was not returned 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 leak (loss of fluid column during procedure) in this incident 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: 7570302
• MDR Text Key: 110113112
• Report Number: 2024168-2018-04153
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70731U103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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 (CDS 71006U188)
• Patient Outcome(s): Required Intervention