MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

All available information was investigated and the reported leak was not confirmed during return device analysis as no issues were noted during testing.A review of the lot history record revealed no manufacturing nonconformities reported to this lot that would have resulted in this event.Additionally, a review of the complaint history identified no other similar complaints reported from this lot.All available information was investigated and a conclusive cause for the reported leak could not be determined in this complaint.Based on the information reviewed, there is no indication of a product issue with respect to manufacture, design or labeling.The additional steerable guiding catheter device referenced is filed under separate medwatch report number.

Event Description

This is filed to report leak.It was reported that during preparation of the first steerable guide catheter (sgc 10510r146), the dilator was inserted without issue; however, the column would not hold fluid.Therefore, the sgc was not used in the patient and the a second sgc (10517r206) was selected to be prepared for use.However, the second sgc also failed to hold column during dilatator insertion.Therefore the sgc was not use in the patient.The procedure was successfully completed with the third sgc.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• 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: 12492566
• MDR Text Key: 272136006
• Report Number: 2024168-2021-08274
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10510R146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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