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

Model Number 1616000

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Physical Resistance/Sticking (4012)

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

Event Date 07/05/2022

Event Type  malfunction  

Event Description

It was reported that during a port placement procedure, the guidewire allegedly got caught in the atrium and a strong resistance was felt when the guidewire was attempted to be withdrawn.It was further reported that the guidewire was removed and some tissue pieces were attached to the tip of the guidewire.Reportedly, another guidewire was used to complete the procedure.There was no reported patient injury.

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.(expiration date: 03/2023).

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, dimensional and functional evaluations were performed on the returned device.The investigation is inconclusive for the reported physical resistance/sticking and difficult to remove issues as the exact circumstances at the time of the reported event cannot be verified.Based on the measurements recorded 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.H10: d4 (expiry date: 03/2023).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 during a port placement procedure, the guidewire allegedly got caught in the atrium and a strong resistance was felt when the guidewire was attempted to be withdrawn.It was further reported that the guidewire was removed and some tissue pieces were attached to the tip of the guidewire.Reportedly, another guidewire was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during a port placement procedure, the guidewire allegedly got caught in the atrium and a strong resistance was felt when the guidewire was attempted to be withdrawn.It was further reported that the guidewire was removed and some tissue pieces were attached to the tip of the guidewire.Reportedly, another guidewire was used to complete the procedure.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, dimensional and functional evaluations were performed on the returned device.The investigation is inconclusive for the reported malposition, physical resistance/sticking and difficult to remove issues as the exact circumstances at the time of the reported event cannot be verified.Based on the measurements recorded 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.H10: d4 (expiry date: 03/2023).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: POWERPORT CLEARVUE 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: 15127663
• MDR Text Key: 302723266
• Report Number: 3006260740-2022-02944
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026447
• UDI-Public: (01)00801741026447
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122899
• 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,Followup
• Report Date: 03/01/2023

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: 1616000
• Device Catalogue Number: 1616000
• Device Lot Number: REFY0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 09/28/2022; 04/17/2023
• Supplement Dates FDA Received: 10/04/2022; 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• 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