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

Model Number SGC0701

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 06/07/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the compromised sterility.It was reported the steerable guide catheter (sgc) blue packaging box was crushed.The white pouch around the sgc tray has tear, sterility was compromised.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported tear, rip or hole in device packaging (sterility breached) was confirmed via returned device analysis as the shelf carton and sterile pouch were observed to be damaged.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on available information, a cause of the reported tear, rip or hole in device packaging (sterility breached) with damaged shelf carton and sterile pouch could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442-4628 ; 6517565400
• MDR Report Key: 14754178
• MDR Text Key: 295150014
• Report Number: 2024168-2022-06653
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20222R308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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