MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV, 3FR SL, FULL; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	3173108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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 guidewire was confirmed, but the exact cause was unknown.Two guidewires were received within their hoops.The blue tip straightener was not present on either hoop.The floppy end of each guidewire was protruding from the distal end of the hoop.One guidewire was found to be kinked 1.6cm from the distal weld tip.A microscopic examination reveals dislocations in adjoining coils where the wire was kinked.It is unknown if the kinked wire was the cause or the result of the reported difficulty with advancement and removal.The floppy tip on the other guidewire was slightly curled, but was not kinked and no damage was noted in the coils.The wires were removed from their hoops and no other damage was observed.A tactual investigation revealed that the weld tips were secured to the center core wire.The outside diameter of each wire was within the specification limits.A microscopic examination revealed a smooth finish at the transition between each core wire and the coil wire.No manufacturing defects were noted on the samples.Exactly when or how the wire was kinked cannot be verified with the evidence provided for investigation.It was unknown if any complications associated with the clinical setting affected the functional performance of the returned device.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
(b)(6) 2016- per sales representative, facility stated they "have noticed their success rates with placements has decreased since the perceived change in wire (approx since last fall).They are noticing that the ¿new¿ wire has two transition areas within the wire, as opposed to one.The wire is essentially getting hung up during placements/catching on the vessel wall, making it hard to advance and remove.It is described as being less smooth.Also, upon removal it is noticeable that the wire is much more ¿crooked¿ upon retrieval.".

• Brand Name: POWERPICC SV, 3FR SL, 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: 6113216
• Report Number: 3006260740-2016-00608
• Device Sequence Number: 783727
• Product Code: LJS
• UDI-Device Identifier: 00801741027529
• UDI-Public: (01)00801741027529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/30/2016

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3173108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2016
• Initial Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1