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

Catalog Number SGC01ST

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.There was no damage to the soft tip reported by the account; however, the sgc used during the procedure was returned with tears identified in the soft tip, which is indicative of the clip getting caught on the guide tip during removal of the cds (as reported by the account).Based on visual inspection of the returned device, there is no indication of a product deficiency.Potential causes for difficulty retracting the cds into the guide tip, resulting in soft tip tears/damage can be caused by, but are not limited to, manufacturing anomalies (inner diameter [id] of the tip not within specification), user technique or procedural conditions (curves on the guide during cds removal).As part of the mitraclip manufacturing process, all devices are subject to 100% visual and functional inspection to verify product quality.Review of the device history record (dhr) confirmed this device passed all in-process and final inspections, including verification that the id of the soft tip met specification.A review of the dhr revealed no non-conformances associated with the lot.A query of the electronic complaint handling database indicated there had been no similar soft tip tears/detachment incidents reported for this lot.Based on the information reviewed, there is no indication of a product deficiency.

Event Description

This is being filed as the steerable guide catheter was returned to abbott vascular with a damaged soft tip.Although there was no adverse patient effect, a damaged tip has the potential to cause or contribute to patient injury.It was reported that prior to the insertion of the mitraclip devices, due to the patient anatomy, the transseptal puncture was difficult and was placed 4.5cm above the mitral annulus.Due to the extensive height, the sgc p steering knob and cds m knob were used allowing the clip to be in the correct position and cross the valve.After grasping the clip to the leaflets, when the arm positioner was turned twice to close the clip it became stuck.The clip had been closed to approximately 55 degrees, but could not be closed any further.The arm positioner was opened a few turns and closed again, but the arm positioner stopped with a heavy resistance in the same position and could not be turned any further.The clip was then opened in the inverted position and retracted into the left atrium.The clip closed to 10 degrees.It was decided to remove the cds from the anatomy; however, as the clip had a 10 degree opening, it was not possible to pull the cds back into the sgc.The cds became stuck on the tip of the sgc.With the clip outside of the sgc, the two devices were carefully retracted out of the anatomy as one unit.

Manufacturer Narrative

(b)(4).Event description continued: there was no damage to the septum and no shunt developed.Due to the length of the procedure, the mitraclip procedure was aborted.The patients functional mitral regurgitation (mr) grade remained at the preprocedure grade of 4.Post procedure, due to the patients pre-existing comorbidities and prior heart surgery, the patient was in a very bad condition and the physician was not sure if the patient could undergo heart surgery.Eight days post procedure the patient was reported to be stable.No additional treatment was administered.Per the physician, the length of the procedure was due to the device issue.The physicians were planning on speaking to the patient regarding another mitraclip procedure as the patient needs a solution for the mr.No additional information provided.The steerable guide catheter has been received for investigation.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced has been filed under another manufacturer reference number.

• 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: 4322564
• MDR Text Key: 12794079
• Report Number: 2024168-2014-08098
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2014

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: 03/31/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10354805
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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: MITRACLIP SYSTEM