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

Catalog Number SGC0101

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and the reported tear of the steerable guide catheter (sgc) soft tip was confirmed.All soft tip material was accounted for and there were no other damages observed on the device.A review of the lot history record revealed no non-conformances that would have contributed to the reported event and a review of the complaint history for this lot did not indicate a manufacturing issue.Potential causes for the reported tear in the sgc soft tip can include, but are not limited to, patient conditions, procedural conditions (retraction of the clip delivery system into the sgc under fluoroscopy), manufacturing anomalies (diameter of soft tip), or removal technique of the clip from the sgc soft tip.Based on the information reviewed, it was determined that the tear of the sgc soft tip was a result of procedural conditions (the clip being caught on the sgc soft tip) and is not an indication of a product quality deficiency.

Event Description

This report is filed for the damage to the steerable guiding catheter soft tip, which has potential for injury.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4.During the procedure after the first clip was deployed, a second clip delivery system (cds 40512u1/(b)(4)) was prepared for use with no device issues.There was no resistance felt during insertion or advancement of the second cds through the steerable guide catheter (sgc).There were no challenging anatomical features.Upon steering the clip down to the mitral valve it was observed that the clip was not steering properly as it moved upward towards the left atrium roof versus downward.At this point blue line misalignment was suspected.Prior to removing the cds, the sgc tip was straightened.During retraction of the cds into the sgc, the clip became stuck on the soft tip of the sgc; however, it was able to be maneuvered (slight turns) and removed.After removal of the clip, the sgc soft tip was observed to be torn.The clip arms had been confirmed to be fully closed during retraction and the retraction was visualized under fluoroscopy.After removal of the cds it was confirmed that the blue alignment lines were misaligned.A new cds was used without issue to complete the case.Two clips were successfully implanted reducing the mr to 1-2.The patient was stable post procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant product: mitraclip clip delivery system, implanted mitraclip (x1).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The clip delivery system referenced is filed under a separate medwatch report number.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER (SGC)
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4056083
• MDR Text Key: 12363792
• Report Number: 2024168-2014-05651
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2014

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: 10/31/2014
• Device Catalogue Number: SGC0101
• Device Lot Number: 10309275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2014
• Initial Date FDA Received: 09/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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: CONCOMITANT MEDICAL DEVICES
• Patient Age: 86 YR