MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SHERLOCK 3CG TCS SENSOR REFURBISHED; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number 9770131R

Device Problem Malposition of Device (2616)

Patient Problem Ventricular Tachycardia (2132)

Event Type  Injury  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Per picc nurse: there was a situation with a picc that was placed (b)(6) 2018.Picc team was called by the rn and told the chest x-ray from (b)(6) 2018 showed the picc tip in the right atrium.The patient had been having runs of v-tach and no one notified team until today.Radiology was called and the radiologist looked at it and told to pull it back 5 cm, which picc nurse did.The picc was originally confirmed by 3cg and the picture had looked good.Ecg confirmation and chest xrays provided by picc team.Ekg in ecg confirmation looks to have some interference in the wave form.

Manufacturer Narrative

03/26/2019 - the following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the reported issue of picc malposition is inconclusive as the physical sample was not returned for evaluation.Sales rep indicated there were no further issues with the equipment after additional training was provided to the users, however, details on training provided could not be obtained.It cannot be determined from the chest x-ray whether or not the picc was malpositioned.The ecg strip appears to show some interference in the external ecg waveform, but none in the intravascular waveform.Without a clear, consistent p-wave to use as a reference in the external ecg waveforms, the ifu advises not to rely upon sherlock 3cg tcs placement confirmation to eliminate chest x-ray confirmation.It is possible the interference observed in the external ecg waveform may have led to the picc malposition due to lack of p-wave reference, however, this cannot be determined with the limited information available.The root cause of the event is therefore inconclusive.The device has not been returned to the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Per picc nurse: there was a situation with a picc that was placed (b)(6) 2018.Picc team was called by the rn and told the chest x-ray from (b)(6) 2018 showed the picc tip in the right atrium.The patient had been having runs of v-tach and no one notified team until today.Radiology was called and the radiologist looked at it and told to pull it back 5 cm, which picc nurse did.The picc was originally confirmed by 3cg and the picture had looked good.Ecg confirmation and chest xrays provided by picc team.Ekg in ecg confirmation looks to have some interference in the wave form.

• Brand Name: SHERLOCK 3CG TCS SENSOR REFURBISHED
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: sydney freckleton ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225992
• MDR Report Key: 7451988
• MDR Text Key: 106247163
• Report Number: 3006260740-2018-00796
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9770131R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention