MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT 13F BASIC KIT; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON IMPLANTED

Model Number	5618200
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/06/2018
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, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the wire kinked during application and perforated a vessel as well as the lung.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the wire kinked during application and perforated a vessel as well as the lung.It was reported that in general the patient is not very stable, but not linked to incident, even though it created risk to the patient (pneumothorax).The patient now has a pleura drainage.The vessel itself was ruptured, but there is no bleeding.The catheter was removed and no new catheter was placed (another band at another place).

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT 13F BASIC KIT
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7310902
• Report Number: 3006260740-2018-00338
• Device Sequence Number: 1261148
• Product Code: NIE
• UDI-Device Identifier: 00801741041990
• UDI-Public: (01)00801741041990
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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 Model Number: 5618200
• Device Catalogue Number: 5618200
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/11/2018
• 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