MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 6F RADIOLOGY BASIC TRAY (TL)(135CM NITINOL GUIDEWIRE); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/21/2017
Type of Reportable Event	Serious Injury
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebp1514 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that a piece of the guidewire had broken off and the patient was immediately transferred to the operating room to have the piece retrieved.Reportedly, the end of the guidewire appeared to be unraveled.
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 reported incident of a broken and unraveled guidewire was confirmed, and it was determined that the guidewire was inadvertently damaged during use.A 0.018¿ x 135cm nitinol guidewire was returned for investigation.The distal 1.8cm of the guidewire was received separate from the remainder of the guidewire.The proximal end of the distal 1.8cm guidewire segment was in a knot.The distal end of the coil wire on the proximal guidewire segment was unraveled and stretched over the core wire.It appeared that the knot created complications that resulted in a break in the guidewire.The coil wire stretched and broke at the proximal end of the knot.The break in the core wire coincided with the knot.The weld tip was present at the distal tip of the guidewire.A microscopic examination of the guidewire revealed residue on the coil wire at the knot.Due to the presence of blood residue on the guidewire, the wire may have inadvertently folded over itself and was twisted into a knot within the vessel.No manufacturing related defects were noted on the complaint sample.A review of the device history record (dhr) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.
Event or Problem Description
It was reported by the facility that a piece of the guidewire had broken off and the patient was immediately transferred to the operating room to have the piece retrieved.Reportedly, the end of the guidewire appeared to be unraveled.

• Brand Name: POWERPICC SOLO CATHETER 6F RADIOLOGY BASIC TRAY (TL)(135CM NITINOL GUIDEWIRE)
• 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: 6865960
• Report Number: 3006260740-2017-01594
• Device Sequence Number: 124876
• Product Code: LJS
• UDI-Device Identifier: 00801741028489
• UDI-Public: (01)00801741028489
• Combination Product (Y/N): N
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3396335
• Device Lot Number: REBP1514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention