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

Catalog Number 1716000J

Device Problems Material Discolored (1170); Fluid/Blood Leak (1250); Fracture (1260); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.The catalog number identified in section has not been cleared in the us but is similar to the powerport slim implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, 6f products are identified.

Event Description

It was reported that post port device placement and during a chemotherapy procedure, the device allegedly had a leak.It was further reported that the physician suspected an occlusion of the catheter.There was no reported patient injury.

Event Description

It was reported that some time post port placement through the left subclavian vein, the device allegedly leaked.The distal segment of catheter and the port system were removed.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one titanium low profile powerport attached to a catheter was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported fluid leak and the identified split and discoloration issue, as a longitudinal split was noted approximately 6.8 cm from the distal end of the cath-lock, discoloration noted around split area and upon infusion of the port body with attached catheter segment, a leak from the longitudinal split was observed.The characteristics of the break are indicative of pinch-off.Pinch-off is known to occur when implanting the catheter into the subclavian vein medial to the border of the first rib, which the user is instructed to avoid in the instructions for use.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.Instructions for use states: the risk of pinch-off syndrome can be avoided by inserting the catheter via the internal jugular vein (ij).Subclavian insertion of the catheter medial to the border of the first rib may cause catheter pinch-off, which in turn results in occlusion causing port system failure during power injection.If we choose to insert the catheter into the subclavian vein, it should be inserted lateral to the border of the first rib or at the junction with the axillary vein because such insertion will avoid compression of the catheter, which can cause damage and even sever the catheter.The use of image guidance upon insertion is strongly recommended.A radiographic confirmation of catheter insertion should be made to ensure that the catheter is not being pinched.H10: g3 h11: h6(device, method, result and conclusion) h10: the catalog number identified in section d4 has not been cleared in the us but is similar to the power port slim implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport slim implantable port, chronoflex single-lumen, 6f products are identified in d2 and g4.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.H3 other text : see h10.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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: 11192130
• MDR Text Key: 227734234
• Report Number: 3006260740-2020-21382
• Device Sequence Number: 1
• Product Code: LJT
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1716000J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other