MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8806061

Device Problems Fracture (1260); Material Separation (1562); Stretched (1601); Deformation Due to Compressive Stress (2889)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported that during a port placement procedure, guidewire allegedly deformed.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one powerport mri isp implantable port kit was returned for evaluation.Functional, gross visual, dimensional and microscopic visual evaluations were performed.The investigation is confirmed for the reported deformation due to compressive stress and the identified stretched, fracture and material separation issues, as uncoiling of the guidewire was noted throughout the first segment.Inner core wires were noted to be protruding throughout the uncoiled area.A complete circumferential break was noted on the distal end.Uncoiling was noted throughout the j-tip guidewire segment.A complete circumferential break was noted to the proximal end of the segment.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The definitive root cause could not be determined based upon 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.(expiry date: 09/2023).

• Brand Name: POWERPORT ISP MRI 6F CHRONW/OS
• 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: 15189920
• MDR Text Key: 304194456
• Report Number: 3006260740-2022-03103
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098963
• UDI-Public: (01)00801741098963
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8806061
• Device Lot Number: REFX3018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• 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