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

Catalog Number 9770131

Device Problem Malposition of Device (2616)

Patient Problem Atrial Fibrillation (1729)

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) review is not possible, as no manufacturing lot number has been provided by the complainant.The device has not been returned to the manufacturer for evaluation.

Event Description

On (b)(6) 2017 clinical engineering contacted bas fa requesting information as to get reasons that a sherlock would show the magnet tracking incorrectly and in particular what would cause the picc to be read as going down but when an x-ray was take the picc was up in the jugular.Biomed conferenced a nurse in the conversation, who explained that she (the nurse) was attempting to place a triple-lumen catheter on a fairly large (female) patient who was experiencing some type of a-fib.Due to the a-fib the rn was not relying on the patients ekg for placement but relying on the magnet tracking of the catheter.The magnet tracking was lost once when coming around into the svc so the rn puled the catheter back and re-calibrated the site~rite 6 and re-advanced the catheter.The magnet tracking was lost a second time but reappeared.The rn stated it looked as if the catheter was going down into the svc.The patient was taken to x-ray for confirmation where the catheter was found to be in the tubular vein.A rapid response team was called and the triple lumen was retracted and removed.The patient had a midline placed instead.Patient was stated to be in stable condition.

• 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: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 6786559
• MDR Text Key: 82467273
• Report Number: 3006260740-2017-01281
• 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: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/10/2017

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 Catalogue Number: 9770131
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention