MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number CK000516

Device Problem Split (2537)

Patient Problem Extravasation (1842)

Event Date 03/21/2018

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was originally reported that there was a picc split identified due to an extravasation event in the patient's axillary region into the surrounding tissues.The facility further clarified that extravasation did not occur as a doppler scan showed no leakage outside the vessel.The catheter was removed and replaced.No further intervention was required.

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 fracture in the catheter was confirmed and the cause appears to be use related.The product returned for evaluation was 4fr s/l groshong picc.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated and a split was observed between the 39 and 40 cm depth marks.The catheter split was typical of flexural fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned.Fracture edges which were rounded and polished due to repeated material wear.'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together.Overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing).An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was originally reported that there was a picc split identified due to an extravasation event in the patient's axillary region into the surrounding tissues.The facility further clarified that extravasation did not occur as a doppler scan showed no leakage outside the vessel.The catheter was removed and replaced.No further intervention was required.

• Brand Name: GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS)
• 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7422540
• MDR Text Key: 105380178
• Report Number: 3006260740-2018-00666
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741107894
• UDI-Public: (01)00801741107894
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 801(E)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CK000516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/16/2018
• 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