MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, CHRONOFLEX, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 7480000

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

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

Event Date 01/30/2023

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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 08/2024).Device pending return.

Event Description

It was reported that during a port placement procedure, guidewire allegedly got stuck inside the patient.Guidewire was pulled forcefully to remove from patient, a significant amount of tissue was observed on the distal tip.The procedure was completed using the same device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one j-tip guidewire was returned for evaluation.Gross visual and dimensional evaluations were performed.The investigation is confirmed for the identified deformation issue as the j-tip of the guidewire was noted to be bent.However, the investigation is inconclusive for the reported entrapment of device issue as the exact circumstance at the time of the event was unknown.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.H10: (expiry date: 08/2024).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.

Event Description

It was reported that during a port placement procedure, guidewire allegedly got stuck inside the patient.It was further reported that, the guidewire was pulled forcefully to remove from patient, a significant amount of tissue was observed on the distal tip.Bleeding was normal.The procedure was completed using the same device.There was no reported patient injury.

Event Description

It was reported that during a port placement procedure, guidewire allegedly got stuck inside the patient.It was further reported that, the guidewire was pulled forcefully to remove from patient, a significant amount of tissue was observed on the distal tip.Reportedly, the bleeding was normal.The procedure was completed using the same device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one j-tip guidewire was returned for evaluation.Gross visual and dimensional evaluations were performed.The investigation is confirmed for the identified deformation issue as the j-tip of the guidewire was noted to be bent.However, the investigation is inconclusive for the reported entrapment of device issue as the exact circumstance at the time of the event was unknown.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.  h10: d4 (expiry date: 08/2024).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.

• Brand Name: VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, CHRONOFLEX, 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: 16495785
• MDR Text Key: 310802112
• Report Number: 3006260740-2023-00696
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2023

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 Model Number: 7480000
• Device Catalogue Number: 7480000
• Device Lot Number: REGY2414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 05/09/2023; 09/19/2023
• Supplement Dates FDA Received: 05/12/2023; 09/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2022
• 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 Age: 45 YR