MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1716000

Device Problems Difficult to Flush (1251); Difficult to Remove (1528); Suction Problem (2170); Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problems Bacterial Infection (1735); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2017

Event Type  malfunction  

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: 05/2015).

Event Description

It was reported that post port device implant, the device allegedly had difficulty in flushing and drawing blood.It was further reported that the patient underwent a surgery to remove the port and catheter; however, could not be removed.There was no reported patient injury.

Event Description

It was reported through the litigation process that post port device implant, the device allegedly had difficulty in flushing and drawing blood and was noted to be occluded.It was further reported that the patient underwent a surgery to remove the port and catheter; however, could not be removed.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation, a medical record review was performed.The investigation is confirmed for the reported material twisted or bent and difficulty in removing catheter issue.According to the medical record, approximately four years post port deployment, the patient presented for port removal as it was no longer needed.The port was dissected from the subcutaneous tissue and delivered through the incision and attempt was made to remove the catheter by pulling gently on the port.The catheter appeared to be adherent under the clavicle and would not release.The port was cut from the catheter and then a guidewire was placed through the catheter.The position of the catheter was checked with fluoroscopy and there was noted to be a loop in the catheter at a site that was felt to be in the vein and the guidewire would not pass through the loop.Despite numerous attempts the catheter could not be removed.A decision was made to leave the catheter in place.However, the investigation is inconclusive for the reported difficult to flush, occlusion and suction issue as the exact circumstances at the time of reported event was unknown.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.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 SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
• 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: 11672085
• MDR Text Key: 245597518
• Report Number: 3006260740-2021-01339
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026744
• UDI-Public: (01)00801741026744
• Combination Product (y/n): N
• PMA/PMN Number: K072549
• 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: 08/09/2021

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1716000
• Device Catalogue Number: 1716000
• Device Lot Number: REXC1195
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR