MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE FULL KIT WITH MICROINTRODUCER; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number	7617408
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2015
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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of rezf2364 showed no other similar product complaint(s) from these lot numbers.
Event or Problem Description
Facility contact reported that a picc in a patient leaked when they were injecting.The picc was removed and contact stated that they found that the wire that remains in the picc had separated.A new picc was placed.No patient injury reported.
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 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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l groshong catheter.The sample was received with an inlaid stylet.Mechanical damage was evident throughout the flushing connector.Several bends were evident along the length of the stylet.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, multiple leaks were observed emanating from between the flushing connector and the 58cm depth marking.Tactile inspection of the sample revealed tensile weakness throughout the catheter.The tensile weakness was the most severe in the vanity of the leaks.Microscopic inspection of the leak site revealed irregular, longitudinally aligned splits.The splits exhibited sharply defined granular surfaces.Following longitudinal bisection of the sample in the vicinity of the splits, inspection of the inside catheter surface revealed abundant abrasion damage.During stylet removal, a complete break was observed in the stylet wire, just distal of the flushing connector stent.Microscopic inspection of the break in the stylet revealed a granular break surface and beach marks.The stylet break features were consistent material failure due to fatigue.It appeared that the flushing connector was manipulated until the stylet broke.The features in the inside catheter surface indicated that the stylet manipulation damaged the catheter, resulting in the observed leak.The product ifu states ¿never use force to remove the stylet.Resistance can damage the catheter.If resistance or bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to normal shape.Withdraw both the catheter and stylet together approximately 2 cm and reattempt stylet removal.Repeat this procedure until the stylet is easily removed.¿.

• Brand Name: 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE FULL KIT WITH MICROINTRODUCER
• 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: 5481647
• Report Number: 3006260740-2016-00080
• Device Sequence Number: 1097059
• Product Code: LJS
• UDI-Device Identifier: 00801741035258
• UDI-Public: (01)00801741035258(17)161228(10)REZF2364
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K034020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2016

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 Expiration Date: 12/28/2016
• Device Catalogue Number: 7617408
• Device Lot Number: REZF2364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2016
• Supplement Report FDA Received Date: 04/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1