MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 3CG 5F TL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refv1434 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

Event Description

It was reported that picc placed using sherlock 3cg was discovered to be 6cm off in tip location, despite having been confirmed in the proper place by 3cg technology.Incorrect placement discovered by incidental x-ray that the patient received unrelated to the picc placement.No other information was provided.

Event Description

It was reported that picc placed using sherlock 3cg was discovered to be 6cm off in tip location, despite having been confirmed in the proper place by 3cg technology.Incorrect placement discovered by incidental x-ray that the patient received unrelated to the picc placement.No other information was provided.

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 batch history, applicable previous investigation(s), applicable manufacturing records, ecg printout analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a discrepancy between the ecg printout and an incidental x-ray was inconclusive due to the sample condition.An ecg printout from a 5fr t/l powerpicc provena catheter placement was returned for evaluation.The p-wave was present, identifiable, and consistent.However, the p-wave in the external waveform was inverted.The wave did appear to peak in the intravascular waveform and does appears to be consistent with a caj placement.However, only the user would be able to tell if they inserted the picc tip deep enough to see the p-wave maximize and then start to diminish or display an initial negative deflection.Because the baseline has an inverted p-wave, the ecg should not be used for confirmation.Possible contributing factors for the inverted p-wave could be an incorrect lead placement (switched leads) or the patient may be in a junctional rhythm.A junctional rhythm may have an inverted p-wave in lead 2.With proper external lead placement (lead 2), the black lead is placed on the right shoulder and the red lead is on the left lower abdomen at the mid-axillary line.The p-wave in lead ii (lead 2) would always have an upright p-wave.Since the printout did not contain the correct p-wave in the external waveform, the instructions for use in this case would be to do a chest x-ray.In addition, without a copy of the radiographic images, a review of the images could not be independently conducted.Possible contributing factors for an ecg printout indicating the incorrect catheter tip location could include patient physiology (e.G., heart rhythm anomalies), the 3cg tcs not properly reading the stylet/ecg (e.G., noise on the signal), or clinical procedure.Possible contributing factors for actual or perceived changes in catheter tip location in the radiographic images could include imaging technique (e.G., projection, patient position, and respiratory pattern), patient movements, or catheter securement method.As the complaint could not be independently confirmed, it will be considered inconclusive.However, the complaint has been recorded and will continue to be monitored as part of ongoing trending.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA 3CG 5F TL
• Type of Device: 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: 13726178
• MDR Text Key: 286992008
• Report Number: 3006260740-2022-00696
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741112720
• UDI-Public: (01)00801741112720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S1385108D
• Device Lot Number: REFV1434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Male