MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebv0370 showed no other similar product complaint(s) from this lot number.H3 other text : not yet returned for evaluation.
Event or Problem Description
It was reported by facility that the nurse attempted to insert a picc into a patient¿s left ac vein, met resistance, and was then unable to withdraw the guide wire.It was stated the rn secured the guide wire, assessed the patient and it was determined that the wire would require surgical intervention in order to remove it.
Additional Manufacturer Narrative
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on a review of this information, the following was concluded: the complaint that the guidewire could not be withdrawn was confirmed, and it appeared that the guidewire was damaged during use.One 0.018¿ x 50cm guidewire was returned for investigation.A knot was observed in the distal coiled segment of the guidewire.The knot was located 5mm from the distal tip of the guidewire.A microscopic examination revealed blood residue within the coils of the guidewire.Dislocations in the coil wire were observed proximal to the knot.The weld tip was present at the distal tip of the guidewire.A tactual investigation revealed that the weld tip was intact.Due to the evidence of use on the guidewire, the wire may have inadvertently folded over itself and was twisted into a knot within the vessel.The knot increased the cross sectional area of the guidewire and most likely caused the reported inability to withdraw.No manufacturing related defects were noted on the complaint sample.A review of the device history record (dhr) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebv0370 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by facility that the nurse attempted to insert a picc into a patient¿s left ac vein, met resistance, and was then unable to withdraw the guide wire.It was stated the rn secured the guide wire, assessed the patient and it was determined that the wire would require surgical intervention in order to remove it.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 7250083
• Report Number: 3006260740-2018-00152
• Device Sequence Number: 13725780
• Product Code: LJS
• UDI-Device Identifier: 00801741096273
• UDI-Public: (01)00801741096273
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000408
• Device Lot Number: REBV0370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 04/06/2018
• 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: Required Intervention