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

Catalog Number SGC0302

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The other steerable guide catheter (80924u146) device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report a leak.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.During preparation of the first steerable guide catheter (sgc 80723u203) while inserting the dilator, a leak was observed.Preparation was attempted five times, but the sgc continued to leak.The sgc was not used in the patient, and was replaced.The second sgc (80924u146) was advanced to the mitral valve.Next the first clip delivery system (cds) was advanced and it was noted that the patients oxygen level dropped.The oxygen level was controlled by the anesthesiologist.The procedure was continued, and the clip was deployed.As the cds was being removed, a shunt in both directions was observed.The physician stated the drop in oxygen level was associated to the shunt.A second clip (80905u147) was advanced to the mitral valve to further reduce mr; however, the clip would not open smoothly when the lock lever was pulled to position of the blue line and the lock line was loose.Trouble shooting was performed, and the clip was able to open.The clip was deployed and the cds was removed.The shunt was treated with an atrial septal defect (asd) closure device.Two clips were implanted, reducing mr to 1.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was returned.All available information was investigated, and the reported leak was not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported.Additionally, a review of the complaint history identified no lot-specific product quality issue from this lot.The discrepancy between what was reported (leak) and what was observed (no leak) is likely due to a user technique while inserting the dilator or not following the steps outlined in the instruction of use (ifu) during the device prep versus the returned product analysis contributed to the reported leak; however, this cannot be confirmed.All available information was investigated and a definitive cause for the reported leak 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: 8663088
• MDR Text Key: 146831271
• Report Number: 2024168-2019-04298
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80723U203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• 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