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

Catalog Number SGC0101

Device Problems Break (1069); Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

This report is filed for the tear on the soft tip of the steerable guide catheter noted during returned device analysis.A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the anatomy.It was reported that during a mitraclip procedure, the steerable guide catheter (sgc) crossed the septum and the clip delivery system (cds) was advanced through the sgc.At this point, it was noted that the tip of the sgc was not responding to the minus knob.The user was trying to steer towards the valve in the left atrium, but the sgc tip was not deflecting.The customer thought a pop sound was heard when minus knob was initially turned.The cds was intended to be retracted into the sgc for removal from the anatomy, but the sgc slipped into the right atrium.The sgc was unable to be re-advanced to the left atrium, so the cds was retracted into the right atrium and into the sgc.There was no resistance noted with removal of the cds from the sgc.A second sgc was used with the same cds without incident.One mitraclip was deployed reducing the mitral regurgitation from grade 4 to 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Subsequent abbott vascular preliminary analysis of the returned sgc, (b)(4) 2015, revealed the soft tip was torn.Inspection under keyence microscope confirmed that all soft tip material was present.

Manufacturer Narrative

(b)(4).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

Subsequent to the previously filed report, additional information was received that the steerable guide catheter (sgc) was not curving when the plus knob was turned in the left atrium.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the complaint device was returned for evaluation.The reported cable break resulting in inability to straighten the steerable guide catheter (sgc) tip upon turning the minus knob was confirmed via returned device analysis.The reported mechanical issue of unable to curve the sgc guide tip upon turning the plus knob was not confirmed via returned device analysis.The reported noise and device slippage could not be replicated in a testing environment.The investigation concluded that the device slippage and cable break resulting in noise and mechanical issues of sgc unable to straighten the guide tip was related to user technique.A definitive cause for the reported mechanical issue of unable to curve the sgc guide tip and observed soft tip tears could not be determined.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 similar incidents reported from this lot for reported issues.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 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: 4892086
• MDR Text Key: 20149291
• Report Number: 2024168-2015-03727
• 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: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 50127U222
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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
• Treatment: MITRACLIP CLIP DELIVERY SYSTEM
• Patient Age: 86 YR
• Patient Weight: 104