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

Catalog Number SGC0302

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device 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.The two mitraclip clip delivery systems are being filed under separate medwatch report # s.

Event Description

This is filed to report the steerable guide catheter as the suspected cause of irregular movement in the clip delivery systems.It was reported that this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr).The clip delivery system (cds) was advanced through the steerable guide catheter (sgc).When the m (medial) knob was turned on the mitraclip's steerable sleeve handle, the clip was noted to move in the opposite direction, away from the mitral valve.The blue alignment markers were aligned, but the cds was removed and replaced with a new cds, but it was the same result with use of the m knob.The clip moved away from the valve when the m knob was turned.The cds was removed.Since two cdses reacted in the same way, it was suspected that the issue may have been the sgc; therefore, the sgc was removed and replaced with a new sgc and a new cds.The procedure continued and one mitraclip was implanted reducing mr grade to 1.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: the steerable guide catheter (sgc) was received and device analysis was performed.The reported device operates differently than expected was not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Review of the complaint history identified no similar incidents reported from this lot.A definitive cause for the reported device operates differently than expected could not be determined.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
• MDR Report Key: 8515131
• MDR Text Key: 142339404
• Report Number: 2024168-2019-02919
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80921U224
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2019
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TWO CLIP DELIVERY SYSTEMS
• Patient Age: 85 YR
• Patient Weight: 38