MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PG PRO 18G 10CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned for evaluation.
Event or Problem Description
It was reported "nurses attempted place catheter and successfully placed in the vessel and threw her wire and partially advanced catheter and met resistance.Pulled back catheter smoothly and then tried to pull back wire and had resistance during pull back and then a portion of the catheter broke off in the patients vein.Patient had to go to surgery to remove object.Occurred on (b)(6), 4 to 5cm of wire left in patient and confirmed in vein by cardiovascular physician." add info rcvd 12/15/2020: customer attempted to place the powerglide pro rt catheter and the a portion of the guidewire broke during an attempt to retract the catheter back to pull out catheter.

• Brand Name: DOT PG PRO 18G 10CM FULL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11109200
• Report Number: 3006260740-2020-21150
• Device Sequence Number: 16408887
• Product Code: FOZ
• UDI-Device Identifier: 00801741110566
• UDI-Public: (01)00801741110566
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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 Model Number: N/A
• Device Catalogue Number: F118101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention