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

Catalog Number SGC0301

Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report a tear in the steerable guide catheter (sgc).It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.During advancement of the sgc, resistance was met with the patients tortuous anatomy above the common femoral artery and the sgc became torn one inch proximal to the sgc tip.The sgc was removed and replaced.A new sgc was used to continue the procedure.One clip was implanted, reducing the mr to 1.There were no adverse patient effects and no clinically significant delay in the procedure.

Manufacturer Narrative

Internal file number - (b)(4).The reported device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported failure to advance steerable guide catheter, resulting in the reported tear in the shaft appears to be related to patient morphology/pathology due to the reported tortuous anatomy.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: 8296541
• MDR Text Key: 134738082
• Report Number: 2024168-2019-00742
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80907U156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 55