MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F

Model Number 1808560

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Naturally Worn (2988); Migration (4003)

Patient Problems Swelling (2091); Injury (2348)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer and the evaluation is still pending.The investigation of the reported event is currently underway.(expiration date: 06/2022).

Event Description

It was reported that during the powerport placement procedure, the catheter allegedly had a break at the hub of the port and migrated to the patient's heart.It was further reported that the cardiologist retrieved the catheter and replaced with another catheter.The patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one mri was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.Multiple punctures were observed on the port septum.Apparent tool damage was noted on the sides of the port body.Remarkable tool damage was noted on the cath-lock.A complete circumferential break was noted at the distal end of the cath-lock.The distal segment was not returned.The splitting of the catheter at the distal end of the cath-lock indicates the flexural fatigue.The investigation is confirmed for catheter break/fracture, wear, kinking and migration as a complete circumferential break was noted and catheter breaks inside the patient.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 06/2022), g4,h6(device: 2889).H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that approximately one year post powerport placement, the catheter allegedly had a break at the hub of the port and migrated to the patient's heart.It was further reported that the cardiologist retrieved the catheter and replaced with another catheter.The patient status is unknown.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10188528
• MDR Text Key: 196217318
• Report Number: 3006260740-2020-02189
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027116
• UDI-Public: (01)00801741027116
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REDR3581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention