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

Catalog Number SGC0101

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer reported the sgc was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The cds is filed under a separate medwatch report number.

Event Description

This is filed to report that during removal of the clip delivery system (cds), the clip became caught on the steerable guiding catheter (sgc) soft tip, causing a soft tip tear which has the potential to cause or contribute to serious injury.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.The cds was advanced.Visualization was difficult while the cds exited the sgc, so subtle movements were made to get the clip in plane.The visualization was better, and straddling was performed.Thrombus was then noted on the clip; therefore, the cds was retracted, possibly too quickly, and the clip became caught on the sgc tip.The clip was slightly opened and advanced in an attempt to free it from the tip, but was unsuccessful.The patient became slightly hypotensive and a pericardial effusion was observed.The clip was tightly closed on the soft tip, and the devices were retracted to the femoral vein.There was resistance between the clip and the vessel; therefore, the devices were left in place and a pericardiocentesis was performed to treat the effusion.A cut-down procedure was then performed to remove the cds and clip.After removal, it was observed that the clip was only attached to the shaft with the lock and gripper lines.Additionally, the soft tip of the sgc was torn.No clips were implanted and the mr remained at 4.The patient was confirmed to be stable post-procedure, and no further treatment has been planned.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and the tears in the soft tip appear to be related to procedural conditions due to the clip becoming caught on the tip.Based on the information reviewed, there is no indication of a product quality issue 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 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: 5941343
• MDR Text Key: 54761637
• Report Number: 2024168-2016-06000
• 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
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

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: 01/31/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60108U232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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: MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM
• Patient Age: 68 YR
• Patient Weight: 65