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

Subsequent to the initial medwatch report, the additional information was received: the third clip delivery system ((b)(4)) release pin was removed.The actuator knob was rotated 8 times counterclockwise and the actuator knob was not fully retracted to release the clip.

Event Description

This mitraclip report is being filed as the steerable guide catheter (40717u112) had soft tip damage.Although there were no adverse patient effects reported due to this, soft tip damage can cause or contribute to patient injury.It was reported that the first clip delivery system (cds) (40717u322) was inserted and advanced through the neutral steerable guide catheter (sgc) (40717u112), without resistance, in a patient with degenerative mitral regurgitation (mr) of 4.The device was in the left atrium and upon m knob application, the device deflected towards the pulmonary vein.No grasping was attempted and no tissue damage was noted.During cds removal, the clip caught the side of the sgc tip.Careful pressure was applied to the clip to move it forward off the sgc tip.The physician suspected sgc tip damage so both the cds and the sgc were removed separately.Soft tip tear was noted, on the sgc, once removed.There was no reported embolization.Another sgc was inserted and another cds was successfully advanced and the clip was successfully implanted, reducing the mr to 2.A third cds (40609u407) was advanced and properly straddled.The clip grasped the leaflets successfully.Upon the final clip deployment, the release pin was not pulled back enough and the release groove was not fully exposed.The entire dc handle was moved back, removing the clip from the delivery catheter and from the leaflets, into the left atrium.There was no leaflet or cardiac damage due to the clip detachment.

Manufacturer Narrative

(b)(4).Event description continued: using the gripper lines, the clip was pulled into the inferior vena cava (ivc) and then to the femoral vein where it was surgically removed.The mr remained at 2 and the patient is in stable condition.Reportedly, the patient experiences shortness of breath (sob), without treatment, since the procedure.There was no additional information provided.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.The first clip delivery system (cds) referenced and the third cds referenced are being filed under separate medwatch mfr numbers.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and the reported tear of the steerable guide catheter (sgc) soft tip was confirmed.All soft tip material was accounted for.In an effort to replicate the difficulty retracting the clip into the guide, the returned sgc and returned clip delivery system (cds) were inserted into a 37 degrees celsius water bath with a simulated inferior vena cava to simulate a clinical condition.The returned cds was fully inserted and upon removal, it was noted that the clip did not become caught on the sgc soft tip.A proxy cds was fully inserted into the returned sgc.Upon removal, the clip did not become caught on the sgc soft tip.Potential causes for difficulty retracting the clip into the guide, resulting in the reported tear in the sgc soft tip can include, but are not limited to, patient conditions, user technique/procedural conditions (curves on guide during cds removal), or manufacturing anomalies (inner diameter [id] of the tip not within specification).A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database indicated there had been no similar soft tip damage incidents reported for this lot.With respect to procedural conditions and/or user technique, difficulty retracting the clip into the guide and associated tearing of the sgc soft tip can be influenced by the clip not being fully closed upon removal, removal technique (the orientation of the clip with respect to the guide tip) or curves on the sgc applied by the user, resulting in the clip becoming caught on the sgc soft tip.In this case, the information provided in the case details stated that the patient had a rotated heart and the transseptal puncture was too high.Upon sgc removal from the patient anatomy, a tear was noted in the sgc soft tip.Follow up with the account confirmed that the clip arms were fully closed upon removal and there were no extreme curves on the sgc.Based on the information reviewed, the tear observed in the sgc soft tip was determined to be related to user technique/procedural conditions (the clip becoming caught on the sgc soft tip), as the challenging patient anatomy and removal technique likely resulted in the clip becoming caught on the sgc soft tip.Troubleshooting maneuvers performed to remove the clip from the sgc soft tip which resulted in the reported tear.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: 4182459
• MDR Text Key: 5007803
• Report Number: 2024168-2014-06789
• 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: 40717U1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 10/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2014
• 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: OTHER: 1 CLIP DELIVERY SYSTEM
• Patient Age: 89 YR
• Patient Weight: 70