MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV 4F DL MAX 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refs1619 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by bd rep "the insertion was ultimately successful, so the nurse requested an x-ray to confirm tip location.The nurse also noted that the guidewire was bent near the tip after the insertion.The x-ray revealed a ~ 1.9-2cm piece of the guidewire that had fractured off and was found in the axilla region." add info received: did the patient require surgery to remove the broken piece? endovascular retrieval was attempted but unsuccessful.Providers opted to not pursue surgical removal due to risk of surgery compared to lower risk of just leaving retained piece behind were all the missing/broken pieces retrieved and accounted for? no, unable to retrieve broken piece was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.Broken piece had already migrated to left ventricle.Last imaging studies show broken wire fragment (approx.1.9 cm) lodged in the tricuspid cordae.Patient does not appear to be symptomatic as a result of the broken wire fragment.
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: previous complaints, patient severity, applicable manufacturing records, submitted photograph, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a break within the 3cg stylet was confirmed, but the exact cause was unknown.A photograph was provided which depicted a 3cg stylet wire.The wire had been placed next to what was presumably a reference (undamaged) stylet.It was confirmed that the stylet contained a complete break within the magnet tip, and that broken segment was not depicted.The damaged stylet also contained kinks within the magnet string.No observable evidence suggested the cause of this event.A review of the manufacture records associated with the provided lot number found no potential cause identified during product manufacture.Should the physical sample be returned at a later time, this investigation will be updated.
Event or Problem Description
It was reported by bd rep "the insertion was ultimately successful, so the nurse requested an x-ray to confirm tip location.The nurse also noted that the guidewire was bent near the tip after the insertion.The x-ray revealed a ~ 1.9-2cm piece of the guidewire that had fractured off and was found in the axilla region." add info received: ¿ did the patient require surgery to remove the broken piece? endovascular retrieval was attempted but unsuccessful.Providers opted to not pursue surgical removal due to risk of surgery compared to lower risk of just leaving retained piece behind.Were all the missing/broken pieces retrieved and accounted for? no, unable to retrieve broken piece.Was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.Broken piece had already migrated to left ventricle.Last imaging studies show broken wire fragment (approx.1.9 cm) lodged in the tricuspid cordae.Patient does not appear to be symptomatic as a result of the broken wire fragment.Medwatch received: difficulty advancing guidewire noted during picc insertion.Guidewire removed and kinks noted.Picc line placed and x-ray used for confirmation d/t tip confirmation system not working correctly.Initial x-ray confirmed picc placed in correct position, along with a small object that could be broken piece of guidewire.Radiologist confirmed a 1.9 cm thin linear radiodensity overlying the right axilla.Patient sent to ir for retrieval, which was unsuccessful d/t broken fragment migrating to tricuspid valve.Decision made to not attempt retrieval due to risk.Patient asymptomatic at this time.

• Brand Name: DOT PROV 4F DL MAX 3CG
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14462425
• Report Number: 3006260740-2022-01875
• Device Sequence Number: 4904204
• Product Code: LJS
• UDI-Device Identifier: 00801741130366
• UDI-Public: (01)00801741130366
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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: S1274108D
• Device Lot Number: REFS1619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 72 KG