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

Catalog Number SGC01ST

Device Problem Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The steerable guide catheter is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report that during preparation of the steerable guiding catheter (sgc) the hemostasis valve was loose; if this were to be occur in the anatomy, a loose rhv has the potential for the device to leak and introduce air into the patient.It was reported that during preparation of the steerable guiding catheter (sgc), the hemostasis valve was rotating at the guide connection and could not be tightened.The sgc was not used in the anatomy and there was no patient involvement.There was no clinically significant delay in the intended procedure.No additional information was provided.

Manufacturer Narrative

Evaluation summary: (b)(4).The incident information provided to abbott vascular, analysis of the returned device, manufacturing records and complaint history for the reported lot were reviewed.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.The reported unstable hemostasis valve appears to be related to the twisted shaft between the hypotube and hemostasis valve; however, a definitive cause for when and how the shaft became twisted was unable to be determined.It is possible that there were torque applied to the hemostasis valve during device preparation or handling that cause the shaft to become twisted; however, this cannot be confirmed.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 5128368
• MDR Text Key: 27851886
• Report Number: 2024168-2015-05852
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: Followup
• Report Date: 11/09/2015

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: 03/31/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50326U101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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