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

Catalog Number SGC0301

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was returned and investigated.The steerable guide catheter (sgc) was noted to have a torn soft tip.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 tears appear to be related to the clip interacting with the guide soft tip or from the metal piece identified on the clip delivery system (cds).Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The clip delivery system referenced is filed under mfr # 2024168-2019-13130.

Event Description

This is filed for a tear in the steerable guide catheter soft tip.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.One clip was implanted without issue.The second clip delivery system (cds) was advanced into the steerable guide catheter (sgc) with some resistance at the sgc hemostasis valve; however, the device was then able to advance.When steering down to the valve, there was some resistance noted when retracting the delivery catheter (dc) handle.On fluoroscopy, an unknown metal object was seen on the cds shaft when testing the clip lock; however, the procedure continued and the clip was deployed without issue.The cds and sgc were removed as a single unit, without resistance.At the back table, the cds was easily removed from the sgc.Upon removal, a scrape was noted, approximately 1 inch from the tip of the cds.A piece of metal was seen, towards the distal end of the sleeve.When the physician touched the metal, it easily came off.There was no adverse patient effect or a clinically significant delay in the procedure.Returned device analysis noted that the soft tip of the sgc was torn; however, all pieces were present.No additional information was provided.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9307573
• MDR Text Key: 177224195
• Report Number: 2024168-2019-13467
• 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
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90719U228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 135