MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN PICC; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problems Kinked (1339); Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem Pain (1994)

Event Type  Injury  

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 yet returned for evaluation.

Event Description

Health professional reported that they attempted to place a picc three times unsuccessfully on (b)(6) 2016.The nurse had to open a separate micro introducer kit.It was reported that the patient came in complaining of a sore arm, went to radiology and had a full 35 cm guidewire from the microintrudcer kit in their arm which had gone into the brachial arterial.The guide wire was completely straight apart from the bottom which had a kink in it.The guidewire became stuck in an arm of the artery, and had not moved any further.The guidewire was said to have a few kinks in it due to being placed into a pot.There was no picc placed, only the guidewire remained in the patient.No patient injury reported.

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 insertion difficulty, and possible guidewire embolism, was confirmed and the cause was likely use related.The product returned for evaluation was a 0.0175¿ x 35cm guidewire.The wire contained multiple kinks and bends throughout the length of the wire.Traces of residual material were also seen throughout the wire.Microscopic examination of the wire revealed many disjoined coils throughout the wire.These disjoined coils were typically associated with the kinks and bends.The sample was still easily fed through a non-complainant introducer needle.There was no observed potential manufacture-related contributing factor towards the reported event and the event situation appeared to be related to user technique.No review of specific manufacture records was possible because the implicated product lot number was not provided.Additionally, as no specific product catalog number or product line was provided a review of the specific literature associated with that product was not possible but a review of the powerpicc ifu, which is a common picc offered through bard, revealed typical warning do exist related to this event type: ¿do not advance the guidewire past the axilla without fluoroscopic guidance or other tip locating methods.¿ ¿keep sufficient guidewire length exposed at hub to allow for proper handling.A non-controlled guidewire can lead to wire embolism.¿.

• Brand Name: UNKNOWN PICC
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-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: 5939830
• MDR Text Key: 54337812
• Report Number: 3006260740-2016-00477
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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