MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8808560

Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

Patient Problems Pain (1994); Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 10/2021).

Event Description

It was reported that during port placement procedure, the device allegedly had difficulties on insertion.It was further reported that guide wire insertion caused perforation of the right ventricle resulting in a small moderate pericardial effusion and retained guide wire post port insertion requiring icu admission and surgical intervention.Patient current status is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation, one medical record was provided for review.The investigation is confirmed for the reported catheter puncture, stylet deformation, improper procedure, pain, perforation and pericardial effusion.According to the medical record, post-operative chest x-ray study showed left sided infusa port line in position and the tip was situated in the right atrium.No pneumothorax and no discrete pulmonary lesion were identified.Normal heart size without pleural effusion.Subsequently, on an unknown date.Patient presented to the emergency department with the complaints of abdominal pain and tachycardia.Diagnosed as hemorrhagic pericardial effusion and presumed sepsis.Patient presented for the port removal.Intraoperative findings demonstrated that the stiffener wire has created a tear and it spared the tip of the catheter but involved the side of the catheter near the tip.The straight end was towards the tip of the catheter and the bent end was towards the infusa port.Eventually, the infusa port was explanted successfully.Post port removal, transesophageal echocardiogram showed mild residual pericardial effusion for ongoing monitoring and patient recovered well.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.The current instructions for use states that, warning: "for implantable ports with groshong* catheters, do not cut stylet.Withdraw stiffening stylet from catheter prior to cutting." the current hang tag, states that, warning: "do not cut stylet-withdraw styet before trimming catheter.H10: d4 (expiry date: 10/2021), g3, h6 (method).H11: b5, h6 (device, result).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 during port placement procedure, the device allegedly had difficulties on insertion.It was further reported that stiffener wire insertion caused perforation of the right ventricle resulting in a small moderate pericardial effusion and retained stiffener wire post port insertion requiring icu admission and surgical intervention.Patient current status is unknown.

• Brand Name: POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL
• 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: 12466658
• MDR Text Key: 271233911
• Report Number: 3006260740-2021-03802
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098994
• UDI-Public: (01)00801741098994
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8808560
• Device Lot Number: REDY0852
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention