MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN); PERCUTANEOUS, IMPLANTED LONT TERM INTRAVASCULAR CATHETER

Catalog Number 3275118

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2016

Event Type  malfunction  

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 (b)(4) showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.

Event Description

It was reported that the guidewire was shredded and "destroyed" after the catheter insertion.

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 following were reviewed as part of this investigation: patient severity, trend 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 stylet was confirmed, and the cause appears to be use related.The stylet from what could be the implicated 5 fr d/l power picc was returned for investigation.It was observed that the coil wire was severely stretched over the core wire of the stylet.The elongation of the coils allowed the wire to become tangled.The distal tip of both the core wire and the coil wire were microscopically examined.The weld tip was not present and the cross section was noted to be flat with striations across a portion of the surface.The striated surface exhibited increased luster compared to the remainder of the cross section.These characteristics indicate that the stylet was severed with a sharp instrument, and most likely occurred when the catheter was trimmed to length.The core wire extended 76.5cm from the black pull tab, which indicates that the stylet was either cut right at the weld tip or up to 1cm from the weld tip.One of the cautions in the ifu states, ¿when trimming the catheter, do not cut stylet.¿.

Event Description

The guidewire was shredded and "destroyed" after the catheter insertion.

• Brand Name: POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN)
• Type of Device: PERCUTANEOUS, IMPLANTED LONT TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 5717851
• MDR Text Key: 48154616
• Report Number: 3006260740-2016-00263
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027918
• UDI-Public: (01)00801741027918(17)180828(10)REZH2231
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Catalogue Number: 3275118
• Device Lot Number: REZH2231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1