MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPICC CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3275135
Health Effect - Clinical Codes	Bradycardia (1751); Laceration(s) (1946); Foreign Body In Patient (2687)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per anesthesia resident: they were attempting to insert a picc line into the patient's left upper arm.While inserting the guidewire they felt resistance and immediately stopped advancing the guidewire.When they gently tried to pull back on the guidewire, it caused a vagal response and the patient became bradycardic.They treated the patient and once she was stable, they attempted again to pull out the guidewire, but still felt resistance.They called for anesthesia help and got an ultrasound.They were able to trace that the guidewire was in the ij.They called for x-ray and a cardiac anesthesiologist also performed a tee and confirm the wire was not in the heart.An x-ray confirmed that the guidewire was in the ij near the head.With the neurosurgery team, x-ray, and cardiac anesthesia present, they attempted to pull out the guidewire.They were able to pull quite a bit of it out, but realized it had unraveled and that the remaining wire was still wire in the patient's ij unmoved.The decision was made amongst the team to continue with the scheduled aneurysm clipping and to have vascular follow to retrieve the remaining guidewire via neck cutdown.Most of the exposed guidewire was cut and the remaining exposed guidewire was secured with gauze and tape.

• Brand Name: POWERPICC CATHETER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 17555492
• Report Number: 17555492
• Device Sequence Number: 3584453
• Product Code: LJS
• UDI-Device Identifier: 00801741027925
• UDI-Public: (01)00801741027925(17)260331(10)REFW1289
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/04/2023
• Report Date (Section F): 08/04/2023

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 Model Number: 3275135
• Device Catalogue Number: 3275135
• Device Lot Number: REFW1289
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 08/04/2023