MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (70 CM GUID; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, labeling, and applicable manufacturing records.Based on a review of this information, the following was concluded: the complaint that the guidewire or any other component from the implicated picc kit caused or contributed to the reported object within the patient was inconclusive due to the sample condition.Three radiographic images were provided for investigation.No physical samples were returned for analysis.Two of the images have an arrow pointing to a long slender object within the thoracic region.The object appears to be consistent with a segment of the guidewire; however it could not be verified from the images that the object was from the implicated picc kit.The literature provided in the kit provides the following cautions regarding the guidewire."do not advance the guidewire past the axilla without fluoroscopic guidance or other tip locating methods." "if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire." it was confirmed that a foreign object was observed on the radiographic images; however, the cause of the reported event and whether the object was a vad component could not be verified from the images.A lot history review (lhr) of recp2552 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on (b)(6) 2018,there was an attempt to pass picc catheter unsuccessfully.According to the report, there was a "certain" resistance in the progression of the guidewire that needed to be drawn for a new puncture attempt.When pulling the guidewire, resistance persisted until it was removed.On (b)(6) 2019: additional information received: the nurses who performed the procedure reported having had no difficulty in introducing and removing the guidewire.The catheter inserted had a length of 10 cm and was removed at 10 cm.No rupture of the catheter was observed.The event was characterized as event with severe damage, requiring follow-up with a cardiologist for 1 year to perform echocardiogram and chest x-ray every 3 months.In discussion with the multidisciplinary team will not be approached surgically due to risk to the patient.Followed up to observe if the fragment is moving and if there is hemodynamic repercussion.On (b)(6) 2019 - the reporting health professional reports there is a fragment in the patient which is "probably" a piece of guidewire.The fragment will not be removed due to the high risk of the procedure.The patient will be followed up to observe if the fragment is moving and if there is hemodynamic repercussion.

• Brand Name: POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (70 CM GUID
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8574770
• Report Number: 3006260740-2019-01248
• Device Sequence Number: 19330807
• Product Code: LJS
• UDI-Device Identifier: 00801741027611
• UDI-Public: (01)00801741027611
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3174155
• Device Lot Number: RECP2552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other