MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F FULL; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	CK0000101
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/19/2015
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rezg1360 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 1/14/2016 - the sales representative reported the following information from his customer: it was decided to abort a picc insertion because the patient's claustrophobia was causing him to be agitated.Later, when the patient was sedated, they placed the picc line.The facility reported that they knew the picc insertion was successful because of the magnetic tracking that was present during it's placement.They reported that a few days following the picc line insertion, a catheter was being placed, and it was noted that a 3cm foreign body was in the patient's heart.It was reported to fa that this was "definitely the stylet", believed to be there from the previous picc line placement.A retrieval was attempted, but it was unsuccessful.The method of retrieval is unknown.Following the event, the staff at the facility "played" with the stylet to see if it easily fell off.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F FULL
• 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: 5408430
• Report Number: 3006260740-2016-00022
• Device Sequence Number: 621430
• Product Code: LJS
• UDI-Device Identifier: 00801741036255
• UDI-Public: (01)00801741036255(17)161231(10)REZG1360
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Report Date (Section B): 01/11/2016

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: 12/31/2016
• Device Catalogue Number: CK0000101
• Device Lot Number: REZG1360
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability