MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER SL 4F RADIOLOGY BASIC TRAY (135 CM NITINOL GUIDEWIRE); PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/13/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reay2307 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
It was reported that when the guidewire was introduced into the right basilic vein and advanced to the distal svc and then the dilator was introduced.The picc catheter was fed into the sheath and the patient began experiencing discomfort.Fluoroscopy revealed that the wire was broken at the junction where tip of dilator meets the wire.The guidewire and sheath were removed.The broken piece of guidewire remained in the patient (right basilica -> right subclavian).Patient was taken to the or and surgery was required by a vascular surgeon to remove the broken pieces of the guide wire.Patient was kept overnight and discharged on (b)(6) 2017.
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 guidewire break was confirmed and the cause was determined to be supplier related.The product returned for evaluation was three 0.018¿ x 135cm nitinol guidewires.Two appeared unused and unremarkable and one was broken into six segments.Some of the segments contained blood-like residue indicating use.Microscopic examination of the fracture sites revealed that all breaks had occurred on a plane at the wire band transition.Further examination showed that the breaks only occurred at the proximal band transition point and that each fracture surface contained severe pitting along the perimeter.Microscopic examination also revealed pitting at the band transition point of several unbroken bands.Each band of the used sample was manually tested for slight shear force and two additional breaks occurred during laboratory testing.The bands of both unused samples were also tested and did not break.These samples were also inspected microscopically for the pitting observed in the used sample and they did not exhibit the same level of pitting seen on the used sample.From the evaluation it appeared that the used sample was susceptible to shear breakage due to the pitting observed at the proximal band transitions seen on many of the bands.The wire is a supplied component and the sample was sent to the manufacturing facility for further review.
Event or Problem Description
It was reported that when the guidewire was introduced into the right basilic vein and advanced to the distal svc and then the dilator was introduced.The picc catheter was fed into the sheath and the patient began experiencing discomfort.Fluoroscopy revealed that the wire was broken at the junction where tip of dilator meets the wire.The guidewire and sheath were removed.The broken piece of guidewire remained in the patient (right basilica -> right subclavian).Patient was taken to the or and surgery was required by a vascular surgeon to remove the broken pieces of the guide wire.Patient was kept overnight and discharged on (b)(6) 2017.

• Brand Name: POWERPICC SOLO CATHETER SL 4F RADIOLOGY BASIC TRAY (135 CM 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: 6446425
• Report Number: 3006260740-2017-00333
• Device Sequence Number: 830220
• Product Code: LJS
• UDI-Device Identifier: 00801741027772
• UDI-Public: (01)00801741027772(17)18531(10)REAY2307
• 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): 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 3194335
• Device Lot Number: REAY2307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 07/14/2017
• 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