MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F NURSE BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER); CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number 3295118

Device Problems Difficult to Remove (1528); Uncoiled (1659); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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 reza0838 showed no other similar product complaint(s) from this lot number.Device not returned.

Event Description

It was reported that upon attempted picc line insertion, supposedly, guidewire was not able to be advanced.It was said that, when the nurse attempted to remove, some resistance was met.When wire was removed, it was noted to be uncoiled.X-ray confirmed a fragment of the line remains in the patients arm but they would not be requiring surgery for its removal.

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 broken guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one nitinol guidewire.Usage residues were observed distal of the transition.A break was observed in the inner core wire approximately 4cm distal of the transition.The outer coil wire was elongated and broken.The weld tip was missing and was not returned for evaluation.The inner core wire exhibited curved shape memory near the break.Microscopic inspection of the break in the inner core wire revealed a dully granular break surface.Material necking was observed in the vicinity of the break.One edge of the break exhibited a region of increased luster.Microscopic inspection of the break in the coil wire revealed a dully granular break surface.The break surface exhibited a concave shape.Material necking was visible in the vicinity of the break.The characteristics of both the inner core and coil wire breaks were consistent with damage caused by tensile stress.The region of increased luster on the edge of the inner core wire break also suggested contact with a hard metal object such as the introducer needle beve.It appeared that the wire was withdrawn against the introducer needle bevel and became stuck.Subsequent pulling resulted in the observed breaks.The product ifu states ¿caution: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿.

• Brand Name: POWERPICC SOLO CATHETER 5F NURSE BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER)
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• 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: 5158002
• MDR Text Key: 28750717
• Report Number: 3006260740-2015-00477
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 10/02/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 3295118
• Device Lot Number: REZA0838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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
• Patient Outcome(s): Required Intervention