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

Catalog Number SGC0302

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is filed to report the steerable guiding catheter leak.It was reported that during preparation of the steerable guiding catheter (sgc), while trying to insert the dilator into the sgc, the hemostatic valve failed to hold column.After repeating dilator insertion three times, the hemostatic valve water level still dropped.The sgc was not used, no patient involvement.A new sgc was used to continue the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.The device was returned and investigated.The returned device analysis did not confirm the reported leak issue as a leak was not noted during returned device analysis.A review of the lot history record identified 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 a definitive cause for the reported leak could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8938181
• MDR Text Key: 168688558
• Report Number: 2024168-2019-11244
• 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: 09/06/2019

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: 03/24/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90325U127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1