MAUDE Adverse Event Report: ABBOTT MEDICAL (SH-PLYMOUTH) CURVED 10CM LONG 10MM TIP 20G; RF CANNULA

Model Number	SMK-C1010-20
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at the end of the procedure when the physician removed the needle from the patient, fragments of the cannula were missing and remain in the patient.The patient has not experienced any adverse or local reactions due to the fragments being left in their body and no interventions are planned to remove the fragments at this time.
Additional Manufacturer Narrative
The device was returned due to the stylet being ¿stuck¿ inside the cannula needle and the needle insulation peeling off.No resistance or other functional anomalies were noted when a stock stylet was inserted and withdrawn through the length of the needle.The white polyester coating was noted to be partially peeled off the outside of the needle.A summary of the toxicological risks of the polyester coating was completed and it was determined that no toxicology-related adverse health effects are expected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the polyester coating peeling off and the reported stylet removal difficulty remains unknown.

• Brand Name: CURVED 10CM LONG 10MM TIP 20G
• Common Device Name: RF CANNULA
• Manufacturer (Section D): ABBOTT MEDICAL (SH-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL (SH-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 14806512
• Report Number: 3005334138-2022-00379
• Device Sequence Number: 4844260
• Product Code: GXI
• UDI-Device Identifier: 05415067028730
• UDI-Public: 05415067028730
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: SMK-C1010-20
• Device Catalogue Number: SMK-C1010-20
• Device Lot Number: 8358600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 04/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown