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

Catalog Number SGC0301

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned.All available information was investigated and the reported detachment of device component (dilator rhv cap) was confirmed.Additionally, the rhv was observed to be broken.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 other incidents reported from this lot.The investigation was unable to determine a definitive cause for the reported rhv cap detachment and broken rhv.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the cap of the rotating hemostatic valve (rhv) on the dilator was closed and flushed without issue.When the cap was being turned to open, the cap fell off.Attempt was made to screw the cap back on, but was not able to be re-attached.There was no patient involvement.Another dilator was used to complete the procedure.No additional information was provided.Analysis of the returned device identified the hemostatic valve was broken at the y connector.

• 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: 9291180
• MDR Text Key: 174670246
• Report Number: 2024168-2019-13316
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90727U211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2019
• 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