MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 9808560

Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524); Device-Device Incompatibility (2919)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during a procedure, the guidewire was allegedly frayed and got stuck to the needle as a result, the device could not be advanced or removed.It was further reported that the guidewire was noted to be broken.The segment was removed from the body.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one introducer needle and guidewire segment was returned for evaluation.Visual, microscopic visual and dimensional evaluation were performed on the returned device.The investigation is confirmed for the reported fracture and identified stretched issues as uncoiling was noted on the outer coils of the guidewire near the j-tip and distal to introducer needle tip, inner core wires were not found inside the stretched area of the guidewire.However, the investigation is inconclusive for the reported failure to advance, difficult to remove and device-device incompatibility issues as the exact circumstances at the time of the reported event are 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.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 procedure, the guidewire was allegedly frayed and got stuck to the needle as a result, the device could not be advanced or removed.It was further reported that the guidewire was noted to be broken.The segment was removed from the body.There was no reported patient injury.

Event Description

It was reported that during a port placement procedure, the guidewire was allegedly frayed and got stuck to the needle as a result, the device could not be advanced or removed.It was further reported that the guidewire was noted to be broken.The segment was removed from the body.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one introducer needle and guidewire segment was returned for evaluation.Visual, microscopic visual and dimensional evaluation were performed on the returned device.The investigation is confirmed for the reported fracture and identified stretched issues as uncoiling was noted on the outer coils of the guidewire near the j-tip and distal to introducer needle tip, inner core wires were not found inside the stretched area of the guidewire.However, the investigation is inconclusive for the reported failure to advance and difficult to remove issues as the exact circumstances at the time of the reported event are 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.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.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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
• MDR Report Key: 12405445
• MDR Text Key: 269296915
• Report Number: 3006260740-2021-03634
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1