MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F BASIC; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refv4116 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the operating surgeon inserted catheter and removed guidewire.During locating the catheter through chest ap, it was noticed that the tip of guidewire is not removed, so surgeon removed the catheter and the broken tip of guidewire was retrieved as well.After the surgery, patient passed away due to deteriorated complications.Patient had several past medical histories, and aspiration pneumonia was implanted.Additional information: did the retained wire cause or contribute to the patient¿s death? no.It was informed from customer that patient passed away because of patient¿s underlying diseases.Was the broken tip of the guidewire stuck in the catheter or was the broken tip of the guidewire in the patient¿s body (outside of the catheter)? patient bp dropped while guidewire inserting, so they tried to remove the guidewire, in this process the guide wire broken off while removing the guide wire.Are the chest ap images available? was there any other imaging taken, if yes, are the images available? unknown.I requested some images file but rejected from hospital.What was the date of the patient death? (b)(6) 2022.Customer informed that patient passed away on the date of (b)(6).Can you please clarify if the patient had aspiration pneumonia prior to the catheter placement of catheter? it was informed that patient had tube implanted due to aspiration pneumonia, but it was uncertain that the tube was still implanted at the time of catheter placement.Did the patient have a new catheter placed after broken catheter/guidewire was removed? unknown.
Event or Problem Description
It was reported that the operating surgeon inserted catheter and removed guidewire.During locating the catheter through chest ap, it was noticed that the tip of guidewire is not removed, so surgeon removed the catheter and the broken tip of guidewire was retrieved as well.After the surgery, patient passed away due to deteriorated complications.Patient had several past medical histories, and aspiration pneumonia was implanted.Additional information: did the retained wire cause or contribute to the patient¿s death? no.It was informed from customer that patient passed away because of patient¿s underlying diseases.Was the broken tip of the guidewire stuck in the catheter or was the broken tip of the guidewire in the patient¿s body (outside of the catheter)? patient bp droped while guidewire inserting, so they tried to remove the guidewire, in this process the guide wire broken off while removing the guide wire.Are the chest ap images available? was there any other imaging taken, if yes, are the images available? unknown.I requested some images file but rejected from hospital what was the date of the patient death? (b)(6) 2022.Customer informed that patient passed away on the date of (b)(6).Can you please clarify if the patient had aspiration pneumonia prior to the catheter placement of catheter? it was informed that patient had tube implanted due to aspiration pneumonia, but it was uncertain that the tube was still implanted at the time of catheter placement.Did the patient have a new catheter placed after broken catheter/guidewire was removed? unknown.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a fractured guidewire was confirmed.The product returned for evaluation was one 20cm powertrialysis dialysis catheter and one 0.035¿ j-tip guidewire.Biological residues were observed throughout the sample components.The guidewire was received in two segments.A non-elongated region of coil wire was completely detached from the remaining wire.The proximal coil wire was elongated in the vicinity of the break.A break was observed in the core wire corresponding to the break in the distal weld tip.The distal weld tip remained attached to the distal coil wire fragment.Microscopic inspection breaks in both the core wire and coil wire revealed granular fracture surfaces.Necking was observed in the vicinities of the breaks.The complaint guidewire outer diameter was measured and found to be within manufacturing specifications.Insertion of a non-complainant guidewire through the returned catheter was successful and unremarkable.The fractures in the core wire and coil wire were consistent with material failure due to tensile (pulling) stress.It appeared that the distal fragment of the guidewire became constrained prior to or during attempted removal through the catheter.The unremarkable insertion of a non-complainant guidewire through the catheter suggested that constraint was not caused by a catheter defect and was more likely the result of insertion against resistance and/or patient anatomy.H3 other text: evaluation findings are in section h11.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F BASIC
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• 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: 14189944
• Report Number: 3006260740-2022-01449
• Device Sequence Number: 11845364
• Product Code: NIE
• UDI-Device Identifier: 00801741041907
• UDI-Public: (01)00801741041907
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 5608200
• Device Lot Number: REFV4116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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 Sex: Unknown