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

Catalog Number SGC0101

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other device referenced is filed under a separate medwatch report.

Event Description

This is filed to report the difficulty removing the clip delivery system (cds) through the steerable guide catheter (sgc), which has the potential to cause or contribute to patient injury.It was reported that on (b)(6) 2016, the patient, with mixed etiology mitral regurgitation (mr), underwent a mitraclip procedure.During the mitraclip procedure, the clip was deployed.The gripper lines were noted to be difficult to remove, as if there was a lot of tension.The lines were pulled slowly and the "m" knob was released.The device was pulled medially to align the device with the clip in an effort to relieve some of the tension.The gripper lines were removed and clip deployment was completed.The cds was retracted into the sgc and resistance was noted.Force was applied, but the cds could not be removed.Fluoroscopy noted that the cds sleeve had a small "waist", as if it were being crunched.The cds was advanced 1-2 cm back into the left atrium, then pulled back aggressively.The cds was able to be removed without patient injury.Upon removal, an indentation was seen at the end of the steerable sleeve and no damage was noted with the sgc.A second sgc was used to deploy a second planned clip, post procedure, the mixed etiology mitral regurgitation was reduced from grade 4 to grade 1.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and although the reported resistance removing the clip delivery system (cds) from the steerable guide catheter (sgc) could not be confirmed, abbott vascular (av) confirmed resistance at the distal end of the sgc, when inserting the cds into the sgc.A search of the complaint handling database was performed and there were no other complaints identified from this lot related to difficulty removing the cds from the sgc.Further assessment was performed per site operating procedures and it was determined that there is no indication that the design or manufacture of the device contributed to the reported event.Av will continue to trend the performance of these devices.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and although the reported resistance removing the clip delivery system (cds) from the steerable guide catheter (sgc) could not be confirmed, abbott vascular (av) confirmed resistance at the distal end of the sgc, when inserting the cds into the sgc.A search of the complaint handling database was performed and there were no other complaints identified from this lot related to difficulty removing the cds from the sgc.Further assessment per site operating procedures was performed and av identified a potential product deficiency related to the manufacture of the device.There is no evidence to indicate that a wider population of product has potentially been impacted.Av will continue to trend the performance of these devices.

• 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: 6149740
• MDR Text Key: 61854709
• Report Number: 2024168-2016-08618
• 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: 02/06/2017

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: 06/30/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60628U130
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/26/2017; 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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 DELIVERY SYSTEM
• Patient Age: 82 YR
• Patient Weight: 101