MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. -9617592 POWERTRIALYSIS SLIMCATH, 15CM; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redv2933 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported guidewire unable to be removed without extreme measures.Placed in rij for vascular access and removed at time of discharge.No other information was provided.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty removing a guidewire is confirmed; however, the exact cause of this difficulty could not be determined from the returned sample.One 0.035 in.¿j¿-tip guidewire was returned for evaluation.An initial visual observation showed use residue on the returned sample.The guidewire was observed to be bent and curved in multiple locations.No breaks were observed in the guidewire during tactile evaluation.A microscopic observation revealed slight separation of the coils of the outer wire of the guidewire at the location of the bends in the guidewire, but no kinks or other damage was found in the returned guidewire.Both weld tips of the guidewire were observed to be present and intact.It is possible the reported difficulties in removing the guidewire were caused by the damage observed in the returned sample.But the exact cause of bends in the guidewire, and ultimately the reported difficulty in removal, is unknown, based off of the evidence observed in the returned sample.The product ifu states: ¿if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resistance before proceeding.Withdraw needle and guidewire if cause of resistance cannot be determined.¿ a lot history review (lhr) of redv2933 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported guidewire unable to be removed without extreme measures.Placed in rij for vascular access and removed at time of discharge.No other information was provided.

• Brand Name: POWERTRIALYSIS SLIMCATH, 15CM
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• MDR Report Key: 9857877
• Report Number: 3006260740-2020-00937
• Device Sequence Number: 2533757
• Product Code: NIE
• UDI-Device Identifier: 00801741107283
• UDI-Public: (01)00801741107283
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 5863150
• Device Lot Number: REDV2933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR