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

Catalog Number SGC0301

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated weight.The steerable guiding catheter (sgc) was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The clip delivery system (cds) referenced in describe event or problem and concomitant medical products is filed under a separate medwatch report number.

Event Description

This is filed to report the resistance noted between the delivery system and the steerable guiding catheter (sgc).It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The sgc was advanced to the left atrium.The clip delivery system (cds) was then advanced through the sgc.When the clip was approximately 10 cm out of the soft tip of the sgc, an unusual amount of resistance was met, and the cds became stuck.The cds was unable to be retracted into the sgc, so the cds and sgc were removed together as a unit.The closed, undeployed clip met resistance at the interatrial septum, but was able to be removed.This resulted in a large atrial septal defect (asd).Dopamine was administered to treat the patient's low blood pressure.Septal tissue was noted on the undeployed clip.A new sgc and cds were used.One clip was successfully implanted, reducing the mr to 1.An amplatzer septal plug was implanted to treat the asd.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis and abbott vascular (av) confirmed the reported resistance between the clip delivery system (cds) and the steerable guide catheter (sgc), and determined it was related to a deformed tip ring on the sgc.Av reviewed the lot history record and there were no manufacturing nonconformities that would have contributed to this complaint.A search of the complaint handling database was performed and there were no other complaints identified from this lot.Further assessment per site operating procedures was performed and identified a potential product deficiency related to the manufacture of the device.The assessment indicates that this is an isolated incident and there is no evidence to indicate that a wider population of product is impacted.Av will continue to trend the performance of these devices.

Manufacturer Narrative

(b)(4).Correction: (b)(4) device coding was added back to report.

• 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: 6425777
• MDR Text Key: 70883018
• Report Number: 2024168-2017-02409
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• 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,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2017
• Device Catalogue Number: SGC0301
• Device Lot Number: 61207U222
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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 Age: 90 YR
• Patient Weight: 52