MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROVIAC 4.2 FR CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF TISSUE INGROWTH; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number 0600520

Device Problems Material Rupture (1546); Stretched (1601); Human-Device Interface Problem (2949)

Patient Problem Vascular Dissection (3160)

Event Date 08/26/2015

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.A lot history review (lhr) of huzb1168 showed two other similar product complaint(s) from this lot number.Both complaints for this lot number (huzb1168) have been reported from the same us facility.The manufacturer has received the sample and will be evaluated.Results are expected soon.

Event Description

Per facility contact, patient was reportedly brought to the peds ed on (b)(6) 2015.While in the ed, the line was flushed but subsequently allegedly ruptured.An internal and external dissection was allegedly noted proximal to the clamping area (where the thin part meets the larger portion).The line was noted to have 2 prior repairs.The line was said to have been purposefully repaired by removing one of the prior splices so that only 2 splices (one new, one old) remained on the line.When patient's mother was told that it looked like the line had been over-stretched, she stated that she saw the patient reportedly pulling on it a lot the day prior ((b)(6) 2015).Mother of patient also stated that she noted a bulge/ballooning effect when she flushed it on (b)(6) 2015.It's likely that the line sustained an internal dissection the day prior and then fully ruptured while the patient was in the ed.

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), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a ballooning catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 4.2fr single-lumen broviac catheter repair segment.Usage residue was seen throughout the sample.The sample terminated 2.8cm distal to the clamping oversleeve.Microscopic examination of the distal end revealed striations typical of a scissor cut.Superficial scoring abrasions were seen in the clamping oversleeve.The markings on the clamping oversleeve were observed to be completed worn off the catheter material.The sample was patent to infusion and aspiration using water from a 12ml syringe with no observed leaks.During hydraulic pressurization, ballooning of the catheter was noted just distal to the clamping oversleeve.Tensile weakness was noted in the ballooning region.Microscopic examination of the ballooning region revealed translucency, indicative of a catheter break of the inner catheter.The characteristics of the catheter damage, as well as the description of the event, are indicative of mishandling of the catheter during use.Care should be taken to avoid pulling the catheter.

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.During year-end review, the initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred per 21 crf803.19.

• Brand Name: BROVIAC 4.2 FR CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF TISSUE INGROWTH
• 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 SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: christy chandonia ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225631
• MDR Report Key: 5082578
• MDR Text Key: 26257646
• Report Number: 3006260740-2015-00418
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0600520
• Device Lot Number: HUZB1168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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