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

Catalog Number SGC01ST

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The clip delivery system (50817u150) is being filed under a separate medwatch mfr number.The steerable guide catheter was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report that during returned device analysis of the steerable guiding catheter, the hemostasis valve bond was found broken, which has the potential to compromise fluid path integrity and lead to air embolism in the patient.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Clip delivery system (cds) 50804u220 met resistance during advancement into the steerable guide catheter (sgc) and was removed without reported issue.Cds 50817u150 also met resistance during advancement into the same sgc.During withdrawal of the cds, resistance was met with the clip introducer and the clip introducer became damaged.The sgc was replaced with a new sgc.Cds 50804u220 was reinserted and the clip was deployed without reported issue.During preparation of cds 50810u120, the delivery catheter (dc) shaft was noted to be bending when the lock lever was retracted; thus, the cds was not used.A new cds was advanced and the clip was deployed without reported issue.The procedure was completed successfully with mr reduced to 1-2, no reported adverse patient effects, and no reported clinically significant delay in the procedure.There was no additional information provided.The sgc was returned with the hemostasis valve bond broken.

Manufacturer Narrative

(b)(4).The complaint device was returned for analysis and the difficulty to insert the clip delivery system (cds) was confirmed.The most probable cause was a loose bond causing a misalignment in the keyway.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 similar incidents for the reported lot.An expanded investigation indicated the most probable root cause of the loose bond was a combination of inherent process variation and variation in physician technique leading to high forces being placed on the bond.Corrective actions to address this issue are in the process of being implemented.The performance of these devices will continue to be monitored.(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: 5306924
• MDR Text Key: 34370618
• Report Number: 2024168-2015-07676
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

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: 07/31/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50727U307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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