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

Catalog Number SGC0101

Device Problems Difficult To Position (1467); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This report is filed as steerable guide catheter advancement resulted in the pacemaker lead to be pulled from the right atrium into the left atrium, requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.During the transeptal puncture the transeptal puncture sheath interacted with the right pacemaker lead, located in the right atrium.Following, the steerable guide catheter (sgc) was advanced into the right atrium, which still contained the right atrium pacemaker lead.While advancing the sgc from the right atrium into the left atrium, the pacemaker lead was accidently pulled with the device into the left atrium.The procedure continued, and 2 mitraclips were implanted without issue.Post procedure, a snare was used to pull the pacemaker lead back into the right atrium without any damage noted.The mitraclip procedure had successful results, reducing the mr to 1-2.There were no adverse patient effects and there was no clinically significant delay.There was no additional information provided.

Manufacturer Narrative

(b)(4).As the device was not returned for evaluation, a failure analysis of the complaint device could not be performed.In addition, a review of the lot history record and complaint history for the reported lot could not be conducted because the lot number was not provided.The analysis of this complaint was an assessment of the information provided to abbott vascular.Difficulty positioning the device (device entanglement) resulting in damage to the pacemaker may be influenced by anatomical morphology/pathology, such as vessel tortuosity, a rotated heart etc.The information provided in the case details stated that the patient did not have a challenging anatomy; however, the patient had a pacemaker.Therefore, this information suggests that the patient morphology/pathology may have contributed to the reported difficulty positioning the device resulting in the device damaged by another due to the user having a pacemaker.Factors related to user technique/procedural condition which can influence the reported difficulty positioning the sgc (entanglement) resulting in the damage to the pacemaker include, but are not limited to, excessive force applied to advance the sgc forward, advancing the sgc with suboptimal visualization.As per the information provided, the transeptal puncture sheath interacted with the right pacemaker lead, located in the right atrium.Following, the sgc advanced into the right atrium, still containing the right atrium pacemaker lead.It was further reported that while advancing the sgc from the right atrium into the left atrium, the pacemaker lead was accidently pulled with the device into the left atrium.This information suggests that the user technique/procedural circumstances contributed to the reported event of difficulty positioning the device (device entanglement) resulting in damage to the pacemaker.All available information was investigated and the reported difficulty positioning the device (device entanglement) resulting in damage to the pacemaker appears to be related to patient morphology/pathology and user technique/procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.(b)(4).

• 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 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5001063
• MDR Text Key: 22884013
• Report Number: 2024168-2015-04610
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC0101
• Device Lot Number: 505057206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 75