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

Catalog Number SGC01ST

Device Problems Kinked (1339); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

This is being filed as returned device analysis of the steerable guide catheter (sgc) found the soft tip was torn.Although there was no adverse patient effect, a torn soft tip has the potential to cause or contribute to patient injury.It was reported that during a mitraclip procedure, there was no resistance noted during the insertion or advancement of the clip delivery system (cds) through the steerable guide catheter (sgc).As per the instructions for use, there were no curves on the sgc during the cds insertion and the cds was not curved more than 90 degrees during preparation or procedure.While positioning the clip in the left atrium, the cds handle was rotated approximately 20 degrees.The stored torque was not released during positioning.While the clip was grasping the leaflet, near the final turns of the arm positioner, resistance was felt and a hard stop occurred.The clip had not completely closed; it was approximately open to 30 degrees.The clip was able to be inverted and retracted into the left atrium.The clip was attempted to be closed several times, but the clip stopped closing at approximately 20-30 degrees each time and the arm positioner always had a hard stop.It was impossible to retract the clip into the steerable guide catheter in the open position.The clip was "attached" to the tip of the sgc and the mitraclip system was removed from the anatomy as one unit.There was no damage to the groin.There was no adverse patient effect.The mitraclip procedure was aborted.The patient will undergo another mitraclip procedure in approximately three weeks.

Event Description

Subsequent to the initial medwatch report, additional information received indicated that the complete mitraclip system was pulled into the groin area and the clip was inverted and pushed back into the iliac vein away from the sgc tip.With the clip delivery system (cds) still in the steerable guide catheter (sgc), the sgc was retracted from the anatomy and then the cds with the inverted clip was retracted.The damage to the sgc soft tip most likely occurred during removing of both devices from the groin; however, the damage was not observed after the devices were removed from the anatomy.The cds and sgc were separated prior to packaging for shipping back to abbott for analysis.A distal kink in the sgc occurred during the procedure.No additional information provided.

Manufacturer Narrative

(b)(4).Event description (cont): the initial device analysis of the returned steerable guide catheter, performed on (b)(6) 2014, found the soft tip was torn with no missing pieces and there was a distal kink in the sgc.Additional reported information indicated that the complete system was pulled into the groin area and the clip was inverted and pushed back into the iliac vein away from the sgc tip.With the cds still in the sgc, the sgc was retracted from the anatomy and then the cds with the inverted clip was retracted.The damage to the sgc soft tip most likely occurred during removing of both devices from the groin; however, the damage was not observed after the devices were removed from the anatomy.The cds and sgc were separated prior to packaging for shipping back to abbott for analysis.The distal kink occurred during the procedure.No additional information was provided.Concomitant products: mitraclip system, clip delivery system.The steerable guide catheter was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced is filed under a separate medwatch mfr number.

Manufacturer Narrative

(b)(4).Evaluation summary: the steerable guide catheter (sgc) was returned for analysis.The sgc soft tip was observed to be torn.Inspection under the (b)(4) microscope revealed that all the soft tip material was accounted for.Soft tip tears are indicative of clip getting caught on the guide tip between the gripper (which contains the frictional elements) and the clip arm.When the clip is caught on the soft tip and is then pushed off tearing can occur.In this case, since the clip could not be fully closed, during attempts to remove the cds from the sgc during procedure and additional attempts post handling resulted in the sgc tears upon removal of the cds from the sgc.Additionally, a kink was identified on the distal end of the sgc and additional follow-up confirmed that the kink was noticed during procedure, and was likely due to the clip not being able to fully close and it getting caught on the sgc.Attempts to remove the opened clip during procedure, likely resulted in the kink on the distal end of the sgc shaft.Therefore, based on the information reviewed, the soft tip tear and kink appears to be related to the clip getting caught on the guide tip.There is no evidence of a product quality deficiency associated with the guide.Review of the device history record confirmed this device passed all in-process and final inspections.There were no non-conformances issued for this lot.A query of the electronic complaint handling database identified no other incidents reported for kink and soft tip tears for the 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: 3907170
• MDR Text Key: 4648337
• Report Number: 2024168-2014-04279
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/16/2014

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: 10/31/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10312815
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 07/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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: 84 YR
• Patient Weight: 58