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

Catalog Number SGC01ST

Device Problems Difficult To Position (1467); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

This event is being filed as the steerable guide catheter (10283825/20) soft tip was torn.The tear has the potential to cause or contribute to patient injury.It was reported that during a mitraclip procedure, after the first clip delivery system (cds) was introduced into the left atrium and as the steerable guide catheter (sgc 10283825/20) handle was turned in the posterior direction (clockwise) for positioning, the sgc tip move anteriorly.It was thought that the sgc was in a more muscular part of the atrial septum and that could have been a factor on the positioning difficulty.As the patient had a rotated heart and a very large left atrium, the cds p steering knob was used to help shed height to get down to the valve despite a reasonable transseptal puncture.The sgc and cds were able to be positioned.The clip was implanted.A second cds (10276655/27) was used and upon inserting the clip into the clip introducer, it became caught in the clip introducer material causing it to fray.As the introducer was outside of the anatomy, it was thought the damage was not significant and the device was continued to be used.The cds and sgc blue alignment lines were in alignment.The cds was advanced to the left atrium.When the cds m steering knob was turned, the clip moved in the opposite direction.It was decided to remove the device; however, upon retracting the clip into the sgc, the clip became caught on the sgc soft tip causing the soft tip to tear.

Manufacturer Narrative

(b)(4).Event description continued: as it was difficult to remove the cds, it was decide to try to use it.By maneuvering the clip, it was able to be placed on the mitral valve leaflets.During the gripper line removability test, resistance was felt, but was able to be removed.The clip was implanted.Post procedure, the functional mitral regurgitation grade was reduced from 4+ to 1+ with the implantation of two clips and the patient was clinically stable.There was no significant delay in the procedure due to the device issue.No additional information was provided.Concomitant products: mitraclip system: clip delivery system (x2), lift, support plate, stabilizer.The steerable guide catheter (sgc) was returned and the reported tear in the sgc soft tip was confirmed.Potential causes for the reported torn soft tip and difficulty to position are, but not limited to, manufacturing anomalies, patient morphology, user technique, and procedural conditions.As part of the mitraclip manufacturing process, all devices undergo visual and functional inspections to verify product quality.Review of the device history record confirmed that this device passed all visual and functional inspection requirements.There were no nonconformances identified for this lot that would have contributed to the reported event.A query of the electronic complaint handling database indicated there had been no similar torn material or difficult to position incidents reported for this lot.The user did not report any issues while functionally inspecting the sgc during device preparation, which is an indication that the device was initially functioning properly.With regards to patient morphology, the physician had reported that the sgc was in a more muscular part of the atrial septum.As such, it is possible that the location of the sgc in this anatomy may have induced an unintended force, causing it to turn in the opposite direction.Therefore, patient morphology cannot be ruled out as a contributory cause to this incident.With regards to user technique / procedural conditions, it was reported by the physician that during removal of the cds device the clip became caught on the sgc soft tip, causing the tip to tear.Based on the information reviewed and the analysis of the retuned device, it was determined that this incident can be attributed to patient morphology, user technique, and procedural conditions.The cause for the reported difficult to position the sgc could not be definitively confirmed, but it was reported by the physician that the placement of the sgc in a more muscular part of the atrial septum may have contributed to the observed issue.The cause for the reported tear in the sgc soft tip was found to be due to the clip being caught on the soft tip during removal attempts, as reported by the physician.Through investigational analysis, there is no indication of a product quality deficiency with respect to the manufacturing, design, or labeling of the device.The clip delivery system (10276655/27) referenced being filed under a separate medwatch mfr 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: 3693292
• MDR Text Key: 4293364
• Report Number: 2024168-2014-01713
• 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
• Report Date: 02/25/2014

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: 06/30/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10283825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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: 78 YR
• Patient Weight: 84