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

Catalog Number SGC0302

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2018

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 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.

Event Description

This is filed to report the steerable guide catheter(sgc) soft tip tear.It was reported that this was a mitraclip procedure performed to treat functional mitral regurgitation (mr), with an mr grade of 3-4.The steerable sgc and clip delivery system (cds) were advanced to the left atrium.During positioning of the cds, when the m-knob was applied, the cds went in the opposite direction.The cds was retracted, but the clip became caught on the tip of the sgc.Troubleshooting was performed and ultimately, the clip successfully removed from the sgc.It was noted that a portion of the sgc tip was in the clip.The cds was retracted into the sgc and removed with the clip.The sgc was removed and replaced.A new cds was used without issue.Two clips were implanted, reducing the mr to 1+.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).All available information was investigated and the reported detached soft tip was confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated, and the detachment of 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report, the photo provided was reviewed and it appears that the entire steerable guide catheter (sgc) soft tip detached from the sgc and was caught in the clip.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
• 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: 7738701
• MDR Text Key: 115668100
• Report Number: 2024168-2018-05922
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80405U157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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: CLIP DELIVERY SYSTEM
• Patient Age: 74 YR
• Patient Weight: 54