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

Catalog Number SGC0301

Device Problems Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: all available information was investigated and the reported kinked steerable guide catheter (sgc) tip was confirmed.The returned device analysis confirmed the reported kinked sgc tip as the soft tip circumference was not rounded.The investigation also observed that the soft tip was torn.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.The investigation concluded that the torn and kinked soft tip was due to the clip getting caught on the tip of the sgc.There is no indication of a product quality issue with respect to manufacture, design or labeling.The clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed based on returned device analysis which found that the steerable guide catheter (sgc) soft tip was torn.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.The clip delivery system (cds) was advanced to the mitral valve; however, the cds was inadvertently advanced too far.The cds was retracted back when the clip got caught on the tip of the sgc.The sgc tip became kinked.The clip was not implanted and both devices were removed together and replaced.The procedure was successfully completed with a new sgc and a new cds.Three clips were implanted, reducing mr to 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis found that the sgc soft tip was torn.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: 8582496
• MDR Text Key: 144145106
• Report Number: 2024168-2019-03555
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80828U202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• 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: 90 YR