MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70 CM 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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
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.
Event or Problem Description
It was reported "during this operation, a foreign body remained inside the vein.The patient was transferred the next day for surgery to remove the foreign body.".
Event or Problem Description
It was reported "during this operation, a foreign body remained inside the vein.The patient was transferred the next day for surgery to remove the foreign body." a detailed description of the event: on (b)(6) 2021 there was a picc line installation in fluoroscopy.During this procedure, there remains a foreign body (parcel of the guide?) inside the vein.The patient was transferred the next day to surgery in order to proceed with the removal of the foreign body ( materiel du power picc/guide) what type of catheter securement was utilized: no fixation was used, the event occurred while performing the fluoro catheter.Additional information received: the event took place on (b)(6) 2021.It was during the installation of the picc line, when the guide was removed, that it was realized that part of the guide had remained in the vein.The patient had to undergo surgery the next day to remove the foreign body.¿.
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 following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken guidewire is confirmed.One 0.018 in.Guidewire in a plastic hoop, one sealed 6 fr triple lumen powerpicc kit, and the open kit packaging for another 6 fr triple lumen powerpicc kit were returned for evaluation.An initial visual observation showed the core wire guidewire returned outside of a kit was broken and the coiled wire was unraveled.The weld tip of this sample was found to be missing and was not returned.A microscopic observation revealed the break site of the core wire of this sample was tapered with an angled fracture surface, which was flat and granular in texture.The coiled wire of this sample was observed to be severely unraveled and frayed at its distal tip.No damage was observed on the guidewire returned in the sealed kit.The features observed on the broken guidewire sample indicate it was most-likely broken due to excessive tensile (pulling) force.A lot history review (lhr) of reew2834 showed no other similar product complaint(s) from this lot number.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70 CM 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12616046
• Report Number: 3006260740-2021-04332
• Device Sequence Number: 1295949
• Product Code: LJS
• UDI-Device Identifier: 00801741028038
• UDI-Public: (01)00801741028038
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: 3276355
• Device Lot Number: REEW2834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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