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

Catalog Number SGC0301

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2018

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 was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced is filed under mfr report # 2024168-2018-05638.

Event Description

This is filed to report the soft tip tear in the steerable guide catheter (sgc) found during returned device evaluation.It was reported that a mitraclip procedure was attempted in a patient with grade 3+ mixed mitral regurgitation, a horizontal heart, a small left atrium and an anterior prolapse.The trans-septal puncture was low.The clip delivery system (cds) was advanced through the sgc to the left ventricle.Due to the anatomy, imaging was poor and it was difficult to position the clip.An attempt was made to remove the cds, but resistance with the sgc was noted and it was difficult to get the clip into the sgc.The deliver catheter (dc) handle was rotated 360 degrees, an audible pop was heard and the clip detached from the cds, but remained on the gripper and lock lines.Since the clip could not be completely pulled into the sgc, it was straddled on the tip of the sgc with one clip arm and gripper hanging over the tip of the sgc.The devices were then able to be removed from the patient anatomy.Afterwards, a chordal tear was noted, which was thought to have occurred during removal of the clip from the left atrium.Mr increased to grade 4+.No clips were implanted and no additional intervention was performed.Surgical mitral valve repair is being considered.No additional information was provided.

Manufacturer Narrative

(b)(4).All available information was investigated and the steerable guide catheter (sgc) was noted to have a torn soft tip.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.All available information was investigated the identified tears in the soft tip in this incident appears to be related to the user technique/procedural circumstances of the clip becoming caught on the guide soft tip during removal.The interaction between the clip and guide tip during removal, resulted in the tearing identified in the soft tip.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report, the steerable guide catheter (sgc) and clip delivery system (cds) were returned.The sgc soft tip was noted to be torn, with no missing pieces.Additional follow up indicated that the tear was not noted by the physician.No additional information was provided.

• 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: 7853639
• MDR Text Key: 119498741
• Report Number: 2024168-2018-06946
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80416U113
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/16/2018
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Age: 75 YR
• Patient Weight: 66