MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SHERLOCK 3CG* TCS SENSOR; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); 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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported by the bas tm to fa that a patient went into ventricular tachycardia (vt) shortly after having a picc placed with a site rite 8 ((b)(4)) and sherlock 3cg sensor ((b)(4)) with diamond technology.The rn attributes the vt to malposition of the picc based on sherlock 3cg and diamond readings.The picc trim length was noted at 49 cm.Vt occurred post picc placement.The patients rn pulled the picc line back a few centimeters when vt was noticed while attending to the patient¿s bpap.Vt subsided when rn released the picc but occurred an unspecified time later.It was recommended by the intensivist that the picc was pulled back 12 cm.Radiology pulled the picc back 4 cm and found the picc to be in the lower svc.The patient is now stable and in good condition after several repositions of the catheter.After evaluating the attached images of ecg strips and chest films, it is thought that the issue may be user related where they're relying on the magnet tracking rather than the patient ecg, which is not indicated for proper use in the system ifu.The picc team is fairly new and was unable to start using the 3cg technology due to ultrasound unavailability shortly after training.Fa is working with the tm and dm to get a bas cns or engineer to the hospital site to evaluate the rn's process for placing picc's.Diamond features have been deactivated on the site rite 8 device until the rn's get more training on reading the patient ecg properly.Ongoing follow-up w/sales rep and clinician for more info.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, 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 complaint is inconclusive as only photo samples could be obtained and the physical sample was not returned for evaluation.Photo evaluations were performed and provides evidence suggesting a malpositioned picc, however the root cause could not be determined without physical evaluation of the equipment used.Manufacturing records were reviewed and no potential contributing factors were found during manufacture and quality inspection of the device.

Event Description

It was reported by the bas tm to fa that a patient went into ventricular tachycardia (vt) shortly after having a picc placed with a site rite 8 (b)(4) and sherlock 3cg sensor (b)(4) with diamond technology.The rn attributes the vt to malposition of the picc based on sherlock 3cg and diamond readings.The picc trim length was noted at 49 cm.Vt occurred post picc placement.The patients rn pulled the picc line back a few centimeters when vt was noticed while attending to the patient¿s bpap.Vt subsided when rn released the picc but occurred an unspecified time later.It was recommended by the intensivist that the picc was pulled back 12 cm.Radiology pulled the picc back 4 cm and found the picc to be in the lower svc.The patient is now stable and in good condition after several repositions of the catheter.After evaluating the attached images of ecg strips and chest films, it is thought that the issue may be user related where they're relying on the magnet tracking rather than the patient ecg, which is not indicated for proper use in the system ifu.The picc team is fairly new and was unable to start using the 3cg technology due to ultrasound unavailability shortly after training.Fa is working with the tm and dm to get a bas cns or engineer to the hospital site to evaluate the rn's process for placing picc's.Diamond features have been deactivated on the site rite 8 device until the rn's get more training on reading the patient ecg properly.Ongoing follow-up w/sales rep and clinician for more info.

• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): QUALITEL CORP; 4608 150th ave ne; redmond WA 98052
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6312655
• MDR Text Key: 66859586
• Report Number: 3006260740-2017-00051
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741124341
• UDI-Public: (01)00801741124341
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

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: N/A
• Device Catalogue Number: 9770131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention