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 05/13/2014

Event Type  malfunction  

Event Description

This is being filed as the steerable guide catheter (10299855/06) soft tip became damaged during the removal of the clip.Although there was no adverse patient effect, a damaged tip has the potential to cause or contribute to patient injury.It was reported that the mitraclip clip delivery system (cds 10325065/19) and steerable guide catheter (sgc 10299855/06) were prepared for use as per the instructions for use.The transseptal puncture was in the superior/mid fossa of the atrial septum.The cds was advanced to the small left atrium.After straddling the device with the sgc, the clip became stuck in the pulmonary vein.The smaller left atrium was considered as a contributor to the clip entering the pulmonary vein in addition to user technique.In an attempt to free the clip, the physician pulled the cds back.The cds moved more quickly than expected and the clip became stuck on the soft tip of the sgc.There was no tissue damage to the pulmonary vein.The clip was opened slightly and was able to be removed from the tip.The physician was concerned that some of the soft tip material may have been lodged in the grippers on the clip arms.It was decided to remove the cds.Although it was difficult retracting the closed clip into the sgc as it kept getting caught on the soft tip, the cds was able to be successfully removed from the anatomy through the sgc.The sgc was also removed from the anatomy.After removal of the sgc, damage was seen on the soft tip; there was no damage noted to the clip.

Manufacturer Narrative

(b)(4).Evaluation summary: the steerable guide catheter (sgc) was returned for analysis and visual inspection confirmed the reported tears in the sgc soft tip.The complete soft tip material was found to be present.The reported detachment was not confirmed, however, the physician only suspected that soft tip material may have been lodged in the grippers on the clip arms.Device testing confirmed the reported difficulty retracting the clip into the sgc.Potential causes for difficulty retracting the clip into the sgc tip, resulting in soft tip tears are, but not limited to, anatomical morphology/pathology, procedural conditions (curves on the sgc during removal of the clip delivery system (cds), user technique or manufacturing anomalies.As part of the mitraclip manufacturing process, all devices are subject to visual, dimensional and functional inspection to verify product quality.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 from this lot.There were no reported issues while functionally inspecting the devices during preparation, which is an indication that the soft tip was not damaged prior to use.With respect to the patient condition, procedural conditions and/or user technique, difficulty retracting the clip into the sgc may be influenced by anatomical morphology/pathology, the user not fully closing the clip or straightening the sgc upon removal, or excessive force or range of motion while manipulating the devices.The information provided in the case details stated during the attempt to free the clip from the pulmonary vein, the physician pulled the cds back, but the device moved faster than expected and the clip became stuck on the sgc soft tip.Further attempts to then retract the closed clip into the straightened sgc were difficult as the clip kept getting caught on the soft tip.In this case, it is likely that the clip moved faster than expected due to the clip being freed from the vein while being pulled back, resulting in the clip initially getting caught on the sgc tip.Furthermore, as the analysis confirmed the reported issue, it is possible that as the clip was no longer able to completely close (due to potential interference of internal components) as a result of the attempts to free the clip from the sgc tip initially and therefore, contributed to the difficulty removing the clip during subsequent attempts.Based on the information reviewed, the tears in the soft tip as a result of the clip becoming caught on the sgc tip appear to be related to procedural conditions/user technique and not a product quality deficiency.

Manufacturer Narrative

(b)(4).Event description continued: another sgc and cds were successfully used in the procedure without incident.The mixed mitral regurgitation grade was reduced from 4 to 1 with the implantation of one clip.There was no adverse patient effect or significant clinical delay in the procedure.The patient was stable throughout and immediately post procedure and was doing well one day post procedure.No additional information was provided.Concomitant products: mitraclip system: lift, support plate, stabilizer, clip delivery system.The steerable guide catheter has been received.It has not yet been received.A follow up report will be submitted with all relevant information.The clip delivery system (10325065/19) referenced is being filed under a separate manufacturing report 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: 3854242
• MDR Text Key: 4683103
• Report Number: 2024168-2014-03638
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• 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: 10303405
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2014
• 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