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 Disconnection (1171); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/31/2022

Event Type  Injury  

Event Description

It was reported that approximately four months and twenty days post port placement procedure on the right internal jugular vein for chemotherapy, an x-ray examination demonstrated that the catheter was detached from the port body.It was further reported that the catheter was allegedly migrated into the right atrium.Reportedly catheter and port body were removed.The patient current status is unknown.

Manufacturer Narrative

The catalog number identified 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.As the lot number for the device was not provided, a review of the device history record could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Manufacturer Narrative

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.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport slim implantable port with a catheter and cath-lock was returned for evaluation.Gross visual, microscopic visual, functional testing, tacctile and dimensional evaluations were performed on the returned device.During visual evaluation, a complete circumferential break was noted on the distal end of the returned catheter.Furthermore, striations was noted throughout the surface of the complete circumferential break.However, the investigation is inconclusive for the reported catheter disconnection and migration issues as the exact circumstances at the time of the reported event are unknown and it is unable to confirm/unconfirm the issues based on the returned sample analysis.Based on the measurements recorded including inner diameter of the cath-lock and widest portion of the port stem outer diameter during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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 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.

Event Description

It was reported that approximately four months and twenty days post port placement procedure on the right internal jugular vein for chemotherapy, an x-ray examination demonstrated that the catheter was detached from the port body.It was further reported that the catheter was allegedly migrated into the right atrium.Reportedly catheter and port body were removed.The patient current status is unknown.

• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14727654
• MDR Text Key: 294265475
• Report Number: 3006260740-2022-02306
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111631
• UDI-Public: (01)00801741111631
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

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: 1716000J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention