MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	9385108QD
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 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 of a damaged stylet was confirmed; however, the cause was undetermined.The product returned for evaluation was one photograph depicting a segment of tls stylet.The segment was placed on gauze, next to a ruler.The fragment appeared to include the distal tip and measured approximately 1.3¿ in length.Also received was one photograph depicting the distal end of an undamaged non-complainant stylet.While stylet damage was evident, inspection of the provided photograph was insufficient to determine the root cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of reaq2462 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 07/06/2016- per sales representative the facility reported that on (b)(6) 2016 the picc was inserted via the right cephalic vein.The picc was trimmed 10cm and positioned at the 42cm mark.The chest x-ray taken on (b)(6) 2016 showed appropriate position for the picc tip.It was stated that on (b)(6) 2016 radiology noted a thin metallic object approximately 3cm at level of right axillary vein.The object was removed and discarded by interventional radiology on (b)(6) 2016.A photo was taken of the object and the radiologist reportedly determined it to be consistent with tip of stylet used with the type of picc inserted.

• Brand Name: POWERPICC HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5806743
• Report Number: 3006260740-2016-00358
• Device Sequence Number: 19004510
• Product Code: LJS
• UDI-Device Identifier: 00801741035807
• UDI-Public: (01)00801741035807(17)170928(10)REAQ2462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: 9385108QD
• Device Lot Number: REAQ2462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2016
• Initial Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1