MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARDPORT M.R.I. LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 6.6F OPEN-ENDED; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603880C

Device Problems Break (1069); Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.Device not returned at this time.

Event Description

It was reported that a chest x-ray was performed and found that the port had separated from the catheter and the catheter had migrated to the heart.The catheter and the base of the port were removed successfully.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: dhr was reviewed and no deviations/issues were identified associated with this problem in regards to product materials or during packaging, manufacturing or qc inspection processes.All necessary inspections were performed throughout all the manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot, in regards the problem described.Investigation summary: the device returned was one low profile mri plastic port with catheter.Functional, dimensional, microscopic, and tactual evaluations were performed.The investigation is confirmed for the failure mode of a subcutaneous catheter break, more specifically a break at the port stem.Visual observation found that the catheter was broken, with only a small portion remaining on the port stem.The catheter lock was not present.The larger portion of catheter contained the 1- through 12-cm depth marks.Signs of use were apparent on the port and catheter.Microscopic evaluation found longitudinal splitting at one point on the proximal end of the catheter segment on the port stem, indicative of mushrooming due to excessive advancement of the catheter onto the port stem.The other end, as well as the distal end of the catheter segment on the port stem manifested a break.The material of the distal break surface was found to taper outward producing a cone-like shape.Tensile weakness was manifest along much of the long catheter segment.The widest point of the port stem measured within specification.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.The investigation appears to indicate compression damage to the catheter on the port stem.This can occur when assembling the catheter, catheter lock, and port with the catheter askew/wrinkled, or by advancing the catheter lock while at an angle to the port stem/catheter.It is apparent from splitting at the proximal end of the catheter that mushrooming occurred due to excessive advancement of the catheter onto the port stem.It is a possibility that a damaged or out of specification catheter lock could have contributed to this event, and no catheter lock was returned with the rest of the product, so this determination is not possible.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(b)(4).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.

Event Description

It was reported that a chest x-ray was performed and found that the port had separated from the catheter and the catheter had migrated to the heart.The catheter and the base of the port were removed successfully.There was no reported patient injury.

• Brand Name: BARDPORT M.R.I. LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 6.6F OPEN-ENDED
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7470374
• MDR Text Key: 106831419
• Report Number: 2020394-2018-00511
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111280
• UDI-Public: (01)00801741111280
• Combination Product (y/n): N
• PMA/PMN Number: K924250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0603880C
• Device Lot Number: REAY1821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR