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

Model Number N/A

Device Problems Use of Device Problem (1670); 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

Per picc nurse, after placing a picc using 3cg the patient began v-tach.The picc was confirmed by x-ray to be 5 cm too deep.This system has been working without issue previously.Additional information received by nurse stated that the picc was pulled back 5cm, which resolved the issue.

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: reported complaint of patient going into v-tach as a result of picc malposition could not be confirmed through the photo sample evaluation.The photo sample provides evidence that the catheter was likely to have been placed at max p-wave and placement was likely confirmed at max p-wave with sherlock 3cg technology.The original sherlock sensor was not returned for evaluation.Manufacturing records were reviewed and no potential contributing factors were found during manufacture and quality inspection of the device.The root cause is inconclusive.

Event Description

Per picc nurse, after placing a picc using 3cg the patient began v-tach.The picc was confirmed by x-ray to be 5 cm too deep.This system has been working without issue previously.Additional information received by nurse stated that the picc was pulled back 5cm, which resolved the issue.

• 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: 6335568
• MDR Text Key: 67580158
• Report Number: 3006260740-2017-00083
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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