MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number N/A

Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of complications with the guidewire was confirmed, and the cause appears to be associated with use of the device.No manufacturing defects were observed on the 0.018¿ x 50cm guidewire that was returned for investigation.The color was uniform and no discoloration was observed.The length and diameter of the guidewire were within specification.A tactual investigation revealed that the coil wire was intact and could not be stretched over the core wire.A microscopic examination of the weld tip revealed nothing remarkable.The weld tip was present and intact.A portion of the adhesive fillet was missing from the proximal end of the coil wire.It was reported that the guidewire was retracted through the needle after encountering resistance during advancement.A popping sensation was observed while retracting through the needle.The action of retracting the guidewire through the needle most likely caused a portion of the adhesive fillet to separate from the wire.If the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.A lot history review (lhr) of rebp1643 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility via the sales rep that the nurse was attempting to place a 5fr picc on a patient in the upper extremity brachial vein.The nurse stated that the vein was the appropriate size, compressed well, and no visual recognition of an issue.She inserted the needle and started advancing the guidewire and was met by slight resistance around 4-5 cm, so she stopped.She stated upon removing the guidewire, there was no resistance felt, however upon withdrawing through the needle, there was popping sensation.She stated that the guidewire was intact with no evidence of shearing, but it did not look exactly like the other guidewires they are familiar with.She reported the difference with the guidewires visual representation was in the flexible tip.She stated the tip looked different in color.Additional information received from facility stated, guidewire was removed with needle in place.The patient did well and was not harmed.After this attempt, a peripheral iv 20 gauge was placed in the patients lower arm.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6624760
• MDR Text Key: 77298418
• Report Number: 3006260740-2017-00750
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034558
• UDI-Public: (01)00801741034558(17)180331(10)REBP1643
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/08/2017

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 Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 1275108D
• Device Lot Number: REBP1643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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