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

Catalog Number SGC01ST

Device Problem Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/25/2014

Event Type  Injury  

Event Description

This is being filed as the steerable guide catheter (sgc) was returned to abbott vascular with a torn soft tip and a piece of the soft tip material was missing.Although there was no adverse patient effect, the location of the missing piece of soft tip is unknown and has the potential to cause patient injury if it is in the anatomy.It was reported that during a mitraclip procedure, after the clip delivery system (cds) was advanced into the left atrium (la), due to steering difficulties in the left atrium, the cds with the undeployed clip attached was removed from the anatomy.However, upon retracting the clip into the steerable guide catheter (sgc), it became caught on the soft tip of the sgc.Trouble shooting maneuvers were performed removing the clip from the tip and the cds was removed from the anatomy.There was no resistance reported during the removal of the cds.The clip was not considered as being stuck on the sgc tip, but only caught a little and was not a concern.The sgc was visually inspected post procedure; the soft tip damage was not noted.There was no adverse patient effect.Post procedure, the functional mitral regurgitation grade remained at the preprocedure grade of 3-4.No additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the steerable guide catheter (sgc) was returned and tears in the sgc soft tip were observed; a portion of the soft tip material was observed to be missing and not located with the returned device.This type of tear is indicative of the clip getting caught on the guide tip, resulting in the clip components (frictional elements [fes] of the grippers) digging into and tearing the tip material.No other damage was observed to the device.Potential causes for difficulty retracting the cds into the guide tip, resulting in soft tip tear/damage are, but not limited to, manufacturing anomalies (inner diameter [id] of the tip not within specification), or user technique/procedural conditions (curves on guide during cds removal).As part of the mitraclip manufacturing process, all devices are subject to visual and functional inspection to verify product quality.Review of the lot history record confirmed this device passed all in-process and final inspections, including verification that the id soft tip met specification.There were no manufacturing nonconformities issued to this lot that would have contributed to the reported event.A query of the electronic complaint handling database indicated there had been no other incidents reported for this lot.There were no reported device issues while functionally inspecting the sgc during device preparation, which is an indication that the soft tip was not damaged prior to use.There is no indication that the manufacture of the device contributed to the reported event.With respect to procedural conditions and/or user technique, the clip getting caught on the guide tip, resulting in soft tip damage can be influenced by the clip not being fully closed upon removal, the orientation of the clip with respect to the guide tip or curves on the sgc applied by the user.The analysis of the tear of the returned sgc is indicative of the clip getting caught on the guide tip, between the gripper (which contains the fes) and the clip arm.Additionally, the corresponding cds used in the procedure was returned and analysis of the device confirmed that two fes on one of the grippers were bent.When the clip becomes caught on the guide soft tip, in attempts to release the clip off the soft tip, the cds is advanced, pushing the clip off the soft tip.The fes on the gripper arm can become caught in the soft tip material, resulting in a tear in the guide tip and the bent fes.In this case, follow up with the account confirmed that the clip became caught on the soft tip of the sgc.Under echocardiogram imaging, the grippers were raised and clip slightly opened.After careful advancement of the cds delivery catheter handle, the clip became loose.The clip was locked more tightly, rotation of the clip with dc handle was performed and the clip was advanced to create some separation from the sgc.The clip was retracted and removed from the anatomy.It was further reported that post procedure the device was intensively rinsed and flushed to clean the device before shipping.The soft tip was confirmed to have been inspected and a tear was not observed at the account; no components of the device were reported to have detached inside the patient.However, returned device analysis of the sgc confirmed a soft tip tear.In this case, the returned sgc and corresponding cds were examined and the soft tip tear was determined to be a result of the interaction between the clip (gripper arm and fes) and sgc soft tip.It is possible that after the clip became caught and the soft tip became torn, and upon rinsing the device post procedure, a piece of the material became detached; however, this cannot be confirmed.Based on the information reviewed, the observed tear in the sgc soft tip appears to be related to procedural conditions, as it was confirmed by the account that the clip became caught on the sgc soft tip during removal.However, a definitive cause for the detached soft tip material could not be determined.There is no indication of a product quality deficiency 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 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: 4466979
• MDR Text Key: 5321266
• Report Number: 2024168-2015-00490
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10364155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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, CLIP DELIVERY SYSTEM
• Patient Outcome(s): Other