MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO 5F DL FT 3CG; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	CK000248
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2016
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 wire being difficult to insert through a needle is confirmed, but the cause is unknown.The returned device was one guidewire within its hoop (no j-tip), determined to be 0.0175" od x 50cm at preliminary evaluation.One end was floppy, and one was stiff.The most distal few centimeters manifested a variety of bends.A small amount of residue, possibly blood, was found on the guidewire hoop.Microscopic evaluation showed that while the distal tip was intact, the final, most distal coil was displaced such that it was forced outward from the circumference of the wire, though not broken.At a point around 4.5 cm proximal to the distal tip of the guidewire, it was found that some of the coils were stretched such that they were no longer packed tightly but spaced out.Tactual evaluation showed that the displaced coil on the distal tip was noticeable tactually, and showed that the outer coils at the distal end would not move distally when pulled.Functional testing involved attempting to pass the wire through a 21 ga needle.The passage could be accomplished, with a small amount of resistance, in some cases, but not in others.The complaint is confirmed, but the needle's condition and procedural factors may be pertinent to determining the root cause of this event.In addition, the damage to the wire may have either been a consequence of the reported difficulty of insertion or an original cause or contributing factor thereto.It is possible that the guidewire was retracted against the needle, causing tensile damage to the coils of the guidewire, and then the guidewire was difficult to insert due to catching on the needle or damage related thereto.Difficulty of insertion due to placement technique, etc.May have occurred, either alone or in conjunction with the aforementioned potential contributing factors.The current ifu for the powerpicc solo device states that if the guidewire must be withdrawn while the needle is inserted, the needle and wire should be removed as a unit in order to prevent the needle from damaging or shearing the guidewire.As part of the venipuncture procedure and after insertion of the guidewire, the user is instructed to gently withdraw the safety introducer needle or catheter while holding the guidewire in position.A lot history review (lhr) of 16ab3368 showed no other similar product complaint(s) from these lot numbers.
Event or Problem Description
Facility contact reported to sales representative that during a procedure the tip of wire would not thread through the needle.A new wire was pulled from a new kit.No patient harm.Sample evaluation reveals a frayed guidewire tip and presence of blood residue, indicating this component was likely used on a patient.

• Brand Name: POWERPICC SOLO 5F DL FT 3CG
• 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: 5855148
• Report Number: 3006260740-2016-00398
• Device Sequence Number: 16244136
• Product Code: LJS
• UDI-Device Identifier: 00801741043680
• UDI-Public: (01)00801741043680(17)170630(10)16AB3368
• 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: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2016

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 Expiration Date: 06/30/2017
• Device Catalogue Number: CK000248
• Device Lot Number: 16AB3368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2016
• Initial Report FDA Received Date: 08/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1