MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER 4F MAXIMAL BARRIER TRAY WITH MICROINTRODUCER (S/L); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9194108D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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 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 a damaged guidewire was confirmed but the root cause was undetermined due to the sample condition.One photograph of what appeared to be a nitinol guidewire was provided for investigation.The physical sample was not returned.The photo showed the coil wire stretched over the core wire.The distal end of the coil wire appeared to be tightly coiled.This type of damage can occur if the guidewire is retracted within the introducer needle.It was reported that the guidewire became unraveled during placement.The damage most likely occurred during use from retracting the wire through the introducer needle; however, since the physical sample was not returned for investigation, the exact cause of the damage could not be determined.One of the precautions in the ifu states, ¿if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ a lot history review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 recq0685 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire became unraveled during placement.Inserter met insertion when threading through the introducer needle.It was stated the rn went to remove the wire and it came through the introducer needle sheered.No patient harm occurred during this incident.
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 of a damaged guidewire was confirmed but the root cause was undetermined due to the sample condition.One photograph of what appeared to be a nitinol guidewire was provided for investigation.The physical sample was not returned.The photo showed the coil wire stretched over the core wire.The distal end of the coil wire appeared to be tightly coiled.This type of damage can occur if the guidewire is retracted within the introducer needle.It was reported that the guidewire became unraveled during placement.The damage most likely occurred during use from retracting the wire through the introducer needle; however, since the physical sample was not returned for investigation, the exact cause of the damage could not be determined.One of the precautions in the ifu states, ¿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 recq0685 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire became unraveled during placement.Inserter met insertion when threading through the introducer needle.It was stated the rn went to remove the wire and it came through the introducer needle sheered.No patient harm occurred during this incident.

• Brand Name: POWERPICC SOLO2 CATHETER 4F MAXIMAL BARRIER TRAY WITH MICROINTRODUCER (S/L)
• 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: 7873871
• Report Number: 3006260740-2018-02444
• Device Sequence Number: 14075864
• Product Code: LJS
• UDI-Device Identifier: 00801741035609
• UDI-Public: (01)00801741035609
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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
• Operator of Device: Health Professional
• Device Model Number: 9194108D
• Device Catalogue Number: 9194108D
• Device Lot Number: RECQ0685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1