MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 5F RADIOLOGY BASIC TRAY (DL) (135CM NITINOL GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, "bard power picc line caused an issue with a patient during insertion.The technologist involved reported the incident occurred june 25th.Patient was brought down to interventional radiology for a picc line.During the process of attempting to access a suitable vein and introduce a guide wire, the wire failed and the tip uncoiled.As a result the wire was caught in the patients arm.Attempts were made to remove the wire, once the wire was removed from the patients arm, fluoroscopy was used and showed a small piece of metal was still in the patients skin.Radiologist talked to on call vascular surgeon, more tests being ordered to determine if additional intervention is required.Patient aware of the possibility of foreign object in arm.The patient had further imaging by ct and ultrasound to determine the location of the foreign body.It will then be discussed if the patient will undergo surgery to remove the foreign body.Ct & us shows the foreign body in the soft tissue." additional information received 2 july 2024: a small piece of the metallic distal tip of the advancing wire became stuck just below the skin surface at the level of the brachial vein overlying the mid humeral diaphysis.Radiographs of the humerus were obtained for confirmation.The small retained metallic foreign body measures approximately 3 mm in length.Whether or not this foreign body is located intraluminal or outside of the vein can be confirmed with a follow-up ct examination if required.Vascular surgery consultation recommended.There were not additional immediate complications.The catheter can be used immediately.
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 will evaluate.Results are expected soon.
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.
Event or Problem Description
It was reported, "bard power picc line caused an issue with a patient during insertion.The technologist involved reported the incident occurred (b)(6).Patient was brought down to interventional radiology for a picc line.During the process of attempting to access a suitable vein and introduce a guide wire, the wire failed and the tip uncoiled.As a result, the wire was caught in the patients arm.Attempts were made to remove the wire, once the wire was removed from the patients arm, fluoroscopy was used and showed a small piece of metal was still in the patients skin.Radiologist talked to on call vascular surgeon, more tests being ordered to determine if additional intervention is required.Patient aware of the possibility of foreign object in arm.The patient had further imaging by ct and ultrasound to determine the location of the foreign body.It will then be discussed if the patient will undergo surgery to remove the foreign body.Ct & us shows the foreign body in the soft tissue." additional information received 2 july 2024: a small piece of the metallic distal tip of the advancing wire became stuck just below the skin surface at the level of the brachial vein overlying the mid humeral diaphysis.Radiographs of the humerus were obtained for confirmation.The small retained metallic foreign body measures approximately 3 mm in length.Whether or not this foreign body is located intraluminal or outside of the vein can be confirmed with a follow-up ct examination if required.Vascular surgery consultation recommended.There were not additional immediate complications.The catheter can be used immediately.
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 complaint of a frayed guidewire with a fragment retained was confirmed but the root cause was undetermined.A single fluoroscopic image was provided of the patient¿s right arm.A lateral dual-lumen solo catheter was seen within the image.A tiny focus of increased density was present in the soft tissues adjacent to the proximal picc.The foreign body was nonspecific and could not be conclusively determined to be from the guidewire.However, as the event description stated that the guidewire had uncoiled and caught in the patient¿s arm, the image supported the complainant¿s description of the reported event.Elongation of the coil wire can occur when the inner core wire is either broken or sheared.The exact root cause of the damage could not be determined from the returned image.Microscopic examination and dimensional analysis could not be conducted without the physical sample.Possible contributing factors could include the insertion technique, or the guidewire being retracted through the needle.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, "bard power picc line caused an issue with a patient during insertion.The technologist involved reported the incident occurred (b)(6).Patient was brought down to interventional radiology for a picc line.During the process of attempting to access a suitable vein and introduce a guide wire, the wire failed and the tip uncoiled.As a result, the wire was caught in the patients arm.Attempts were made to remove the wire, once the wire was removed from the patients arm, fluoroscopy was used and showed a small piece of metal was still in the patients skin.Radiologist talked to on call vascular surgeon, more tests being ordered to determine if additional intervention is required.Patient aware of the possibility of foreign object in arm.The patient had further imaging by ct and ultrasound to determine the location of the foreign body.It will then be discussed if the patient will undergo surgery to remove the foreign body.Ct & us shows the foreign body in the soft tissue." additional information received 2 july 2024: a small piece of the metallic distal tip of the advancing wire became stuck just below the skin surface at the level of the brachial vein overlying the mid humeral diaphysis.Radiographs of the humerus were obtained for confirmation.The small retained metallic foreign body measures approximately 3 mm in length.Whether or not this foreign body is located intraluminal or outside of the vein can be confirmed with a follow-up ct examination if required.Vascular surgery consultation recommended.There were not additional immediate complications.The catheter can be used immediately.

• Brand Name: POWERPICC SOLO 5F RADIOLOGY BASIC TRAY (DL) (135CM NITINOL GUIDEWIRE)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19777877
• Report Number: 3006260740-2024-03871
• Device Sequence Number: 15523527
• Product Code: LJS
• UDI-Device Identifier: 00801741028120
• UDI-Public: (01)00801741028120(11)240131(17)251031(10)REHZ1003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• 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,Followup
• Report Date (Section B): 11/08/2024

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: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 3295335
• Device Lot Number: REHZ1003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 11/08/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/04/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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 Sex: Unknown