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

Catalog Number SGC0301

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Na.

Event Description

This is filed to report material separation.It was reported that during preparation, while inserting the dilator into the steerable guide catheter (sgc), the dilator caused the silicon seal of the sgc to dislodge.Resistance was also noted when retracting the dilator from the sgc.The sgc was not used in the anatomy and was replaced.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have resulted in this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information reviewed, a definitive cause for the reported material separation could not be determined in this complaint; however, difficult to remove appears to be a cascading effect of dislodged silicone seal.There is no indication of a product issue with respect to manufacture, design or labeling.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.

• 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: 8860715
• MDR Text Key: 153269980
• Report Number: 2024168-2019-10574
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• 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
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

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: 05/15/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90515U143
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1