MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. X-PORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 7707540J

Device Problems Kinked (1339); Material Deformation (2976)

Patient Problems Swelling (2091); No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  malfunction  

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 effusion from the puncture site and swelling of the patient's skin were observed.X-ray fluoroscopy revealed that the catheter was kinked.The port system was removed and a new device was implanted two days later.There was no reported patient injury.

Event Description

It was reported that effusion from the puncture site and swelling of the patient's skin were observed.X-ray fluoroscopy revealed that the catheter was kinked.The port system was removed and a new device was implanted two days later.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: the sample was returned was evaluation.Visual, microscopic, tactual, and functional evaluations were performed of the physical sample.The investigation was unconfirmed kink and confirmed for flexural fatigue.The catheter was split distal to the cathlock.The fracture has smooth, rounded sections and peeled/granular sections, oval orifices, which is consistent with flexural fatigue.The investigation indicates that the root cause is flexural fatigue, which is related to clinical conditions.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.H11:section a through f - 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.

• Brand Name: X-PORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN
• 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: 7470241
• MDR Text Key: 106867207
• Report Number: 2020394-2018-00505
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098246
• UDI-Public: (01)00801741098246
• Combination Product (y/n): N
• PMA/PMN Number: K022983
• 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: 09/26/2018

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7707540J
• Device Lot Number: REZH0560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 55