MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F MAXIMAL BARRIER TRAY WIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 1194108D

Device Problem Malposition of Device (2616)

Patient Problem Arrhythmia (1721)

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 lot history review (lhr) of reby0838 showed no other similar product complaint(s) from this lot number.[(b)(4)].

Event Description

It was reported that the picc line was placed using sherlock technology.The placement of the picc line in svc was reportedly confirmed via ecg on the sherlock.It was noted that the patient developed arrhythmias after the picc line was place.Md conducted multiple tests over the next 2-3 days to find the source of the arrhythmia.A ct scan showed the catheter in the right atrium.Picc line was pulled back 3cm and placement was verified via chest x-ray.The patient was said to be in normal sinus rhythm while under the care of a vascular rn.Patient was not on telemetry prior to picc placement.Patient underwent a gated cta, chest x-ray, and an echocardiogram as part of the diagnostic analysis for the patient's arrhythmia.The patient was also started on cardizem.The patient did not receive heparin.The picc was secured with a statlock and dressing per protocol and the picc did not migrate per the knowledge of the vascular rn.The picc rn states she had no difficulty with the picc placement.She also noted the patient had a spinal cord stimulator with electrodes in his upper thoracic spine but the battery was dead so the device was turned off.Picc rn states the catheter was advanced until the p-wave spiked and turned green.No negative deflection was ever noted.Normal sinus rhythm reportedly continued throughout placement with no arrhythmia or ectopy noted.Rn states that no complaints or symptoms were noted by the patient during or after placement.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F MAXIMAL BARRIER TRAY WIT
• 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7441943
• MDR Text Key: 105876638
• Report Number: 3006260740-2018-00746
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034510
• UDI-Public: (01)00801741034510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/26/2018,04/18/2018

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 Model Number: 1194108D
• Device Catalogue Number: 1194108D
• Device Lot Number: REBY0838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 129