MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP W/ 8FR GR; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 7707540J

Device Problems Fracture (1260); Difficult to Remove (1528); Stretched (1601); Physical Resistance/Sticking (4012)

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

Event Date 02/08/2022

Event Type  malfunction  

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 guidewire loaded into a one introducer needle was returned for evaluation.Gross, microscopic visual, dimensional evaluation and functional testing were performed.The investigation is inconclusive for the reported guidewire removal and physical resistance and sticking issues as the exact circumstances at the time of the reported event are unknown and the sample evaluation results indicating difficulty under laboratory conditions are not by themselves sufficient to confirm this event occurred under clinical conditions.The investigation is confirmed for the identified fracture and stretched issue as the proximal end of the guidewire was noted to be uncoiling within the introducer needle hub and a complete break to the round core wire was present in the guidewire.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded were not found out of tolerance.A definitive root cause for the reported failure could not be determined based upon the provided 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.The catalog number identified has not been cleared in the us but is similar to the x-port isp with groshong catheter products that are cleared in the us.The pro code and 510 k number for the x-port isp with groshong catheter products are identified.(expiry date: 05/2023).

Event Description

It was reported that during a port placement procedure, the guidewire allegedly got stuck and unable to be removed from the introducer needle.There was no reported patient injury.

• Brand Name: X-PORT ISP W/ 8FR GR
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14336602
• MDR Text Key: 291212186
• Report Number: 3006260740-2022-01700
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098246
• UDI-Public: (01)00801741098246
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022983
• 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: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7707540J
• Device Lot Number: REFQ3607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• 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