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

Catalog Number SGC01ST

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The mitraclip device referenced is being filed under a separate medwatch report.

Event Description

This event is filed for difficulty removing the device, requiring surgical intervention.It was reported that on (b)(6) 2016, the patient, with functional mitral regurgitation, underwent a mitraclip procedure.The steerable guide catheter (sgc) was advanced into the patient anatomy.The clip delivery system (cds) was inserted into the sgc and advanced for positioning.Some difficulty was noted visualizing the clip during the staddling process.A pericardial effusion was noted, and an attempt was made to remove the cds; however, the cds was stuck in the sgc and could not be removed.It was verified that the clip was in the closed position and the physician pulled on the cds again, but the cds could not be removed.The cds was flushed, but still could not be removed.Attempts were made to remove the cds and sgc; however, the patient was sent to surgery to remove the devices.The devices were removed, the pericardial effusion was treated with closure of the atrial perforation, and a surgical annuloplasty was performed.The mitral regurgitation was reduced from grad 4 to grade 1-2.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and investigated.The reported difficult clip delivery system (cds) removal was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents reported from this lot.The reported difficult cds removal appears to be related to user technique due to poor visualization causing the user to have difficulty straddling the device and pushing the key past the distal proximal junction.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture 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 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: 5958245
• MDR Text Key: 54998424
• Report Number: 2024168-2016-06178
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60512U201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention; Disability