MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 20G X 8 CM WITH GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	07/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
Customer reported: "on (b)(6) 2023 rn attempted to access cephalic vein with powerglide pro 20g 8cm catheter using ultrasound.On assessment vein easily compressible and able to accommodate size of catheter.Catheter tip appeared to be in center of vessel, rn advanced the guidewire with no resistance.Rn proceeded to advance catheter and felt resistance almost immediately.Because guidewire was already inserted, rn deployed catheter without advancing (moved housing away from patient while deploying catheter).Rn knew catheter was not in correct place therefore attempted to remove catheter, resistance was met so rn stopped and waited a few minutes while another rn went to get heat.After a few minutes rn was able to remove catheter without heat.Tip of catheter did not appear intact and about 1cm was missing.Xray obtained showed ¿ ¿findings most compatible with small retained foreign body within the anterior lateral soft tissues of the distal upper arm¿.Interventional radiology attempted removal via ultrasound and was unsuccessful and clipped vein above catheter tip.Per ir ¿ ¿based on the foreign bodies position and small size of the cephalic vein and associated thrombosis i believe that attempts at removal of this foreign body using a cutdown may cause greater damage than leaving the foreign body in place.Suspect the cephalic vein surrounding this foreign body with thrombosis¿.Vascular surgery then performed a successful ligation of cephalic vein, exploration of cephalic vein and removal of left upper extremity foreign body from a vascular venous structure on 7/18.This did not cause any delay in treatment." additional information from customer response on 07-26-2023.Break was subcutaneous, all pieces removed from patient and accounted for.No images, from post-operative note - ¿we ligated the vein proximally and distally with several silk ligatures and identified the foreign body and the vein was removed en bloc and explored.The foreign body was expressed from the vein and felt to be consistent with the line tip¿.Thrombus has not resolved, no additional treatment for thrombus.Event did not involve an urgent/life-threatening medical situation, did not cause a clinically significant delay.
Event or Problem Description
Customer reported: "on (b)(6) 2023 rn attempted to access cephalic vein with powerglide pro 20g 8cm catheter using ultrasound.On assessment vein easily compressible and able to accommodate size of catheter.Catheter tip appeared to be in center of vessel, rn advanced the guidewire with no resistance.Rn proceeded to advance catheter and felt resistance almost immediately.Because guidewire was already inserted, rn deployed catheter without advancing (moved housing away from patient while deploying catheter).Rn knew catheter was not in correct place therefore attempted to remove catheter, resistance was met so rn stopped and waited a few minutes while another rn went to get heat.After a few minutes rn was able to remove catheter without heat.Tip of catheter did not appear intact and about 1cm was missing.Xray obtained showed ¿ ¿findings most compatible with small retained foreign body within the anterior lateral soft tissues of the distal upper arm¿.Interventional radiology attempted removal via ultrasound and was unsuccessful and clipped vein above catheter tip.Per ir ¿ ¿based on the foreign bodies position and small size of the cephalic vein and associated thrombosis i believe that attempts at removal of this foreign body using a cutdown may cause greater damage than leaving the foreign body in place.Suspect the cephalic vein surrounding this foreign body with thrombosis¿.Vascular surgery then performed a successful ligation of cephalic vein, exploration of cephalic vein and removal of left upper extremity foreign body from a vascular venous structure on 7/18.This did not cause any delay in treatment." additional information from customer response on 07-26-2023 break was subcutaneous, all pieces removed from patient and accounted for.No images, from post-operative note - ¿we ligated the vein proximally and distally with several silk ligatures and identified the foreign body and the vein was removed en bloc and explored.The foreign body was expressed from the vein and felt to be consistent with the line tip¿.Thrombus has not resolved, no additional treatment for thrombus.Event did not involve an urgent/life-threatening medical situation, did not cause a clinically significant delay.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a damaged powerglide pro catheter was confirmed.The product returned for evaluation was 20ga x 8cm powerglide pro midline catheter.The catheter had been advanced and was returned without the housing assembly.The catheter terminated approximately 7.5cm from the molded joint.The break exhibited a tapered profile.Microscopic inspection of the break site revealed a partially glossy fracture surface.A longitudinally aligned scoring mark was observed on the inside surface of the catheter shaft leading into the break site.The break features and longitudinal scoring mark were consistent with damage initiated by contact with the introducer needle tip during device insertion.Such damage may occur if the catheter is withdrawn onto the needle and if the needle is re-inserted following catheter advancement.

• Brand Name: BASIC KIT 20G X 8 CM WITH GUARDIVA
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17491173
• Report Number: 3006260740-2023-03418
• Device Sequence Number: 20656430
• Product Code: FOZ
• UDI-Device Identifier: 00801741140471
• UDI-Public: (01)00801741140471
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: F120087T
• Device Lot Number: REGZ1824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG