MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 4808560

Device Problems Fracture (1260); Device Tipped Over (2589); Migration (4003)

Patient Problems Pain (1994); Numbness (2415)

Event Date 06/05/2019

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 not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 03/2021).

Event Description

It was reported that post port device implant, the patient allegedly experienced numbness and pain.It was further reported that the device was explanted and replaced.However, the injury was suspected to be because of the device leak, which should have been caused due to device fracture.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that post port device implant, the patient allegedly experienced numbness and pain.It was further reported that the device was explanted and replaced.However, the injury was suspected to be because of the device leak, which should have been caused due to device fracture.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: the sample was not returned for evaluation, a medical record review was performed.The investigation is confirmed for the reported port flipped issue.According to the medical record, approximately one year and ten months post filter deployment, contrast evaluation of a subcutaneous chest infusion port revealed that a left-sided chest infusion port with the catheter tip at the confluence of the innominate veins and abutted the right lateral wall of the most proximal superior vena cava.Malpositioned and malfunctioned left chest subcutaneous infusion port noted.Two days later, the patient scheduled for removal and replacement of port device.After the administration of local anesthesia, an incision was made in the left upper chest adjacent to the port reservoir.Using blunt dissection the reservoir was freed, and the port and catheter were removed.They were inspected and confirmed to be removed in their entirety.Successful placement of the right internal jugular vein subcutaneous chest infusion port and removal of the left chest subcutaneous infusion port was achieved.However, the reported clinical conditions alleged in the complaint could not be confirmed from the medical record review.A definitive root cause could not be determined based upon the 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 (expiry date: 03/2021), g3, h6 (method).H11: b5, g2, h6 (device, result, conclusion).H11: section a through f ¿ the information provide by bd represents all 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.H3 other text : device not returned.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11671765
• MDR Text Key: 245585691
• Report Number: 3006260740-2021-01334
• Device Sequence Number: 1
• Product Code: LJT
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4808560
• Device Lot Number: REAT1808
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR