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

Catalog Number SGC0101

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The dilatator was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This report is filed for the cap that fell off and device leak during the procedure which has potential to cause or contribute to serious injury.It was reported that as the dilator on the mitraclip steerable guide catheter (sgc) was being advanced through the femoral vein, the cap of the dilator's rotating hemostatic valve (rhv) was being turned to the open position to allow the guide wire to back out, when the cap fell off.The dilator leaked from the rhv so the device was removed from the patient along with the sgc.The device was replaced without further incident.There was no air embolism in the patient.One mitraclip was implanted reducing mitral regurgitation (mr) grade from 4 to 3.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the dilator was returned and investigated.The reported dilator cap detachment was confirmed.The reported dilator leak; however, was unable to be confirmed.A review of the lot history record revealed no manufacturing nonconformities for the 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 detachment of the dilator cap could not be determined.The returned device confirmed the reported dilator rotating hemostatic valve (rhv) cap detachment, as the cap was received detached from the dilator.The analysis of the device; however, confirmed that the rhv cap functioned as expected once it was pressed back onto the rhv.The reported leak from the dilator rhv; however, was unable to be confirmed.It is possible that the user inadvertently applied some force to the cap while turning it during the procedure, resulting in the reported cap detachment; however, this cannot be confirmed.The reported leak was due to the dilator cap detachment.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.

• 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: 6094898
• MDR Text Key: 59878086
• Report Number: 2024168-2016-07876
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60804U224
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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
• Patient Age: 80 YR
• Patient Weight: 71