MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.The investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report difficult removal of the dilator from the steerable guide catheter (sgc).It was reported that during preparation, the hemostatic valve on the steerable guide catheter (sgc) was very rigid.Resistance was felt when advancing the dilator into the sgc.The dilator could only be advanced and removed with force.The device was not used in the anatomy.There was no visible damage to the sgc hemostatic valve.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned and investigated.The returned analysis could not confirm the product quality problem¿irregular appearance during testing as no damage to the sgc hemostasis valve was found, nor could it confirm the reported difficult to advance-difficult dilator advancement, nor confirm difficult to remove-dilator.The discrepancy between what was reported (irregular appearance,) during preparation and what was observed (no damage to hemostasis valve) was likely due to the user's observation/interpretation of the rigidity of the hemostasis valve.The discrepancy between what was reported regarding difficult to advance- difficult dilator advancement and difficult to remove and what was observed (no difficulty/resistance advancing or removing) was likely due to the user's observation/interpretation of dilator advancement and retraction.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this complaint.Additionally, a review of the complaint history identified no other complaints reported for this lot.It should be noted as per mitraclip instructions for use (ifu) ntr/xtr system ce, states "warning: do not use excessive force to advance or manipulate the guide assembly".Hence, this is improper user technique as excessive force was applied per the account.However, it could not be confirmed whether the user error of applied excessive force led to, or contributed to, any damage to the device, as no damage was observed during return analysis.A cause for the reported product quality problem- irregular appearance, difficult to advance-difficult dilator advancement, and difficult to remove could not be determined.The reported improper or incorrect procedure was due to the force applied to advance the dilator which is deviation from the instructions for use.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10744523
• MDR Text Key: 213691942
• Report Number: 2024168-2020-08956
• 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
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00723U332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1