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

Catalog Number 9770201

Device Problems Unable to Obtain Readings (1516); Retraction Problem (1536); Failure to Advance (2524); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A history review is not possible, as no serial number of the device has been provided by the complainant.The device has not been returned to the manufacturer for evaluation.

Event Description

A study of the clinical impact of the sherlock 3cg tip confirmation system for peripherally inserted central catheters in japan was published in the journal of international medical research.The study was found and reported to fa by bd marketing director.The study reported three cases of technical failure attributed to the following: one case of inability to interpret the magnetic guidance, thus requiring fluoroscopy, and two cases of the inability to extend the catheter forward through the subclavian vein.There were 18 malpositions reported out of 111 procedures in the study.Among the 18 cases, 1 occurred at the upper svc, 6 at the middle svc, and 11 at the right atrium.One upper svc case was extended further for repositioning, and three right atrium cases were retracted to the caj.The other 14 cases could not be repositioned because they were in an adequate position according to the european guidelines -- from the middle svc to the high right atrium.

• Brand Name: SHERLOCK 3CG SENSOR INTERNATIONAL
• 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): QUALITEL CORP; 4608 150th ave ne; redmond WA 98052
• Manufacturer Contact: sydney freckleton ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225992
• MDR Report Key: 7971507
• MDR Text Key: 123937234
• Report Number: 3006260740-2018-02906
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741154560
• UDI-Public: (01)00801741154560
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9770201
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/22/2018
• 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?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1