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

Catalog Number SGC0101

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2014

Event Type  malfunction  

Event Description

This mitraclip report is filed for the tear noted on the soft tip of the steerable guide catheter.A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the patient.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The first clip delivery system (cds) was inserted and advanced through the neutral steerable guide catheter (sgc), without resistance.Once in the small left atrium, the clip delivery system (cds) deflected in an unexpected direction.The cds was repositioned and the cds deflected again.The cds was removed without resistance.Another cds was advanced in the same fashion as the first and this clip was successfully implanted, reducing the mr to 1.Both the cds and sgc were removed.Once the sgc was outside the anatomy, a torn tip was observed on the sgc.Pericardial effusion was noted.The patient experienced hypotension.The effusion was managed via vasopressor medications and fluid boluses.Hospitalization was prolonged due to the effusion.The patient was reportedly in stable condition.The physician suspected the effusion was due to insertion and deflection of the cds in the small atrium.There was no additional information provided.

Event Description

Subsequent to the initial medwatch being filed, additional information was received, regarding the clip delivery system: resistance was met during advancement (straddling) of the first clip delivery system (cds) into the small left atrium.Resistance was with the anatomy, not the steerable guide catheter (sgc).The echo sonographer stated they were close to a structure.It was unknown if the structure was the left atrial appendage or the pulmonary vein.Anterior/posterior torque was possibly applied and the device was cleared from the source of resistance and was within the left atrium.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not complete.A follow-up report will be submitted with all additional relevant information.Mitraclip delivery system (40609u4/(b)(4)), is filed under a separate medwatch manufacturer report.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis, and the reported tear in the soft tip of the steerable guide catheter (sgc)was confirmed during device testing.All soft tip material was present and accounted for.Potential causes for the reported tear in the soft tip can include, but are not limited to, patient anatomy, user technique / procedural conditions (visibility during removal of the cds) or manufacturing anomalies (nonconcentric soft tip, anomalies in the soft tip).With respect to patient anatomy, user technique and/or procedural conditions, the reported tear in the soft tip may be influenced by poor visibility during cds retraction into the sgc, clip arms not being fully closed, or not fully straightening the sgc shaft during removal.Based on the information reviewed, it is possible that during retraction of the first cds device for repositioning / removal, the clip may have interacted with the soft tip, resulting in the observed soft tip damage; however, this cannot be definitively determined.A review of the device lot history record revealed no non-conformances that would have contributed to the reported event.Additionally, a review of the complaint history database indicated there have been no other similar incidents of soft tip tear reported for this lot.Based on the information reviewed, there is no indication of a product deficiency.

• 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 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4174623
• MDR Text Key: 5098414
• Report Number: 2024168-2014-06712
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: SGC0101
• Device Lot Number: 40718U1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 10/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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: 2 MITRACLIP DELIVERY SYSTEMS
• Patient Age: 74 YR
• Patient Weight: 54