MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F KIT (23CM) (STRAIGHT) (WITH TAPE; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5733734
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reaz0376 showed no other similar product complaint(s) from this lot number.The device has not been returned yet.
Event or Problem Description
It was reported that the healthcare professional experienced difficulty removing the wire.Once the wire was removed it was alleged to be frayed.Procedure was completed without any patient injury.
Additional Manufacturer Narrative
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 frayed guidewire was confirmed and the cause was determined to be use related.The product returned for evaluation was a broken 70-cm guidewire.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle (and possible formation of a residue plug within the needle), causing breakage upon retraction.The returned product sample was evaluated and the guidewire was confirmed to be broken with the coil wire being unraveled.It appeared that the inner core wire had broken which allowed the outer coil wire surrounding it to unravel.Microscopic examination of the fracture sites revealed the following: narrowing of the wire cross-section near the fracture site, which is a characteristic feature of a strong pull on the wire.Biological material was also seen on the wire which may have contributed to the observed guidewire fracture as retraction of the wire together with the biological material could have caused the pieces to become stuck.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.The ifu states: ¿if using a micropuncture set, insert the flexible end of the microintroducer guidewire into the needle.Advance the microintroducer guidewire as far as appropriate.Verify correct positioning, using fluoroscopy or ultrasound.Gently withdraw and remove the needle, while holding the guidewire in position.Caution: if the microintroducer guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ ¿remove the needle while holding the guidewire in place.Wipe the guidewire clean and secure it in place.Caution do not pull back standard guidewire over needle bevel as this could sever the end of the guidewire.The introducer needle must be removed first.¿ a lot history review (lhr) of reaz0376 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the healthcare professional experienced difficulty removing the wire.Once the wire was removed it was alleged to be frayed.Procedure was completed without any patient injury.

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F KIT (23CM) (STRAIGHT) (WITH TAPE
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7359527
• Report Number: 3006260740-2018-00485
• Device Sequence Number: 1482123
• Product Code: MSD
• UDI-Device Identifier: 00801741013140
• UDI-Public: (01)00801741013140
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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 Model Number: 5733734
• Device Catalogue Number: 5733734
• Device Lot Number: REAZ0376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1