MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5 FR DL POWERPICC SOLO CATHETER, 70CM NITINOL; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3295355
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, frequency 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 introducer was confirmed, and the damage appeared to be related to use of the device.The distal tip of the vessel dilator exhibited plastic deformation instead of the standard circular orifice with rounded tip.This type of deformation to the vessel dilator material is consistent with damage caused from abrasion as the introducer is advanced over a guidewire.A portion of the edge along the distal tip of the sheath also exhibited compression damage, which can happen if the edge of the sheath inadvertently catches on the surrounding tissue or vessel during insertion.The increased angle between the introducer and the guidewire can be a factor in the damage.The undamaged section along the distal sheath edge revealed what appeared to be a smooth and proper transition.One of the precautions in the ifu states, ¿do not withdraw dilator from microintroducer sheath until sheath is within vessel to minimize the risk of damage to sheath tip.¿ the ifu also states, ¿introduce the microintroducer assembly over the guidewire.Using a twisting motion, advance the assembly into the vessel.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.¿ a lot history review (lhr) of rebp0363 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales rep, the facility reported difficulty inserting the introducer and dilator.It was stated that the dilator frayed at the end and a new one was used to complete the procedure.No patient injury was reported.

• Brand Name: 5 FR DL POWERPICC SOLO CATHETER, 70CM NITINOL
• 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: 6572816
• Report Number: 3006260740-2017-00620
• Device Sequence Number: 16436605
• Product Code: LJS
• UDI-Device Identifier: 00801741028144
• UDI-Public: (01)00801741028144(17)180630(10)REBP0363
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2017

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: 06/30/2018
• Device Catalogue Number: 3295355
• Device Lot Number: REBP0363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2017
• Initial Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1