MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC, SV, 3FR IR W/ NI 135CM GW; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	3173335
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2017
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) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned, at this time.
Event or Problem Description
It was reported that the guidewire could not be removed from the patient because a knot was made in the guidewire.The knot was made when the operator moved the guidewire randomly as the catheter was not inserted smoothly.Axillary vein cutdown was performed to remove the knotted guidewire.The catheter was being placed via right basilic vein for chemotherapy and blood transfusion.The patient was one-month old baby who had leukemia.No patient injury was reported.
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 damaged guidewire is confirmed and was determined to be use related.One segment of a guidewire was returned for evaluation.An initial visual observation showed use residue on the segment of guidewire.The guidewire segment observed to be unraveled and looped around itself on one end.The guidewire segment was also observed to be bent in various locations along its length, but mostly near the ends.A microscopic observation revealed one end of the segment of guidewire was tapered and the fracture surface was granular in texture.The other end of the guidewire segment was observed to be frayed and tapered.The characteristics of both of the fracture sites suggest tensile failure, most-likely during manipulation of the guidewire.
Event or Problem Description
It was reported that the guidewire could not be removed from the patient because a knot was made in the guidewire.The knot was made when the operator moved the guidewire randomly as the catheter was not inserted smoothly.Axillary vein cutdown was performed to remove the knotted guidewire.The catheter was being placed via right basilic vein for chemotherapy and blood transfusion.The patient was (b)(6) baby who had leukemia.No patient injury was reported.

• Brand Name: POWERPICC, SV, 3FR IR W/ NI 135CM GW
• 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: 6746413
• Report Number: 3006260740-2017-01137
• Device Sequence Number: 1371589
• Product Code: LJS
• UDI-Device Identifier: 00801741027550
• UDI-Public: (01)00801741027550
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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 Model Number: 3173335
• Device Catalogue Number: 3173335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Weight: 3