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

Catalog Number 1806060J

Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)

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

Event Date 09/05/2022

Event Type  malfunction  

Event Description

It was reported that during a port placement procedure, the dilator allegedly could not be inserted.There was no reported patient injury.

Manufacturer Narrative

The catalog number has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products are identified.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 6.5fr introducer peel-apart sheath and vessel dilator was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is inconclusive for the reported difficult to insert issue, as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.The investigation is confirmed for the identified deformation issues, as bunching was noted at the distal end of the device.The distal tip of the vessel dilator was noted to be blunt and deformed.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.

• Brand Name: POWERPORT ISP M.R.I. 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
• 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: 15948031
• MDR Text Key: 308066573
• Report Number: 3006260740-2022-05642
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111624
• UDI-Public: (01)00801741111624
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063377
• 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
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1806060J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• 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