MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5F TL HF POWERPICC SOLO TLS, MAX BARRIER STC; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	9395108QD
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2016
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 broken guidewire was inconclusive because the original complaint sample was not returned for evaluation.The product returned for evaluation was one nitinol guidewire.The distal weld tip appeared intact and the sample appeared unremarkable.The wire measured 50cm in length and 0.018¿ in diameter, both of which were within manufacturing specifications.Tactile inspection of the sample was unremarkable.Microscopic inspection of the sample confirmed that the weld tip was intact and unremarkable.No damage or defects were observed along the length of the wire.No damage or defect was observed during evaluation of the returned sample; however, the event description indicated that the original complaint sample was not available for inspection.An undamaged sample was returned to bard access systems for evaluation.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of reap0614 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 06/20/2016 - per sales representative user facility reported that on (b)(6) 2016 a chest x-ray showed a retained foreign body in the left chest of the patient that was not present prior to the insertion of the picc.It was stated that the fragment appeared to be part of the guidewire.The copper wire was disposed of and the facility was unable to examine the wire.The other wire was reportedly intact.The picc catheter was intact and usable with no problems.Per doctor's opinion, any attempt to remove the wire would result in "major" problems for the patient because the patient was too ill.
Event or Problem Description
On 06/30/2016- additional information from facility confirmed that the guidewire fragment migrated into the lung.On 08/09/2016 - clarification received from facility contact: the radiology report states that the small wire fragment is most likely in a branch of the lower lobe pulmonary artery.

• Brand Name: 5F TL HF POWERPICC SOLO TLS, MAX BARRIER STC
• 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: 5774946
• Report Number: 3006260740-2016-00320
• Device Sequence Number: 623063
• Product Code: LJS
• UDI-Device Identifier: 00801741035906
• UDI-Public: (01)00801741035906(17)170728(10)REAP0614
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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,Followup
• Report Date (Section B): 06/15/2016
• Report Date (Section F): 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2017
• Device Catalogue Number: 9395108QD
• Device Lot Number: REAP0614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/13/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2016
• Supplement Report FDA Received Date: 09/14/2016
• 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: Other
• Date Report Sent to FDA: 05/13/2016