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	N/A
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/13/2018
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 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 broken stylet is inconclusive due to poor sample condition.One photo sample of a stylet was returned for evaluation.An initial visual observation of the photo showed what appears to be a portion of a tls stylet.Bends in the stylet are visible through the portion of the stylet showed in the photo provided.The corresponding portion of the broken stylet is not shown.Based on the description of the reported event and photo sample provided, possible contributing causes include damage to stylet during catheter trimming and kink stylet damage.The photo does show a portion of the stylet but it does not show what device it originated from; consequentially, the complaint of a broken stylet is inconclusive due to poor sample condition.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebx2245 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during insertion of a picc, the guidewire broke and was found in the subclavian vein.The patient was taken to surgery and the wire was removed by a vascular surgeon.It was stated the wire was about 3¿ in length.It was later reported that the nurse thought it may be from an old picc placement.
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 break in the tls stylet was confirmed, and the damage appeared to be related to use of the device.The distal 4.3cm segment of tls stylet was returned for investigation.The returned sample resembled the item that was in the provided photograph.The polyimide tubing was bent 1.7cm from the distal tip.The proximal segment of the stylet was not returned for investigation.The proximal end of a magnet was protruding less than ½ mm from the proximal end of the polyimide tubing.Kinks were observed in the polyimide tubing between magnets.This type of damage can occur when the polyimide tubing is kinked and flexed against the magnets.The powerpicc solo ifu states, ¿avoid sharp or acute angles during implantation.¿ the ifu for the 3cg stylet states, ¿ensure that the stylet tip does not extend beyond the trimmed end of the catheter.Extension of the stylet tip beyond the catheter end, combined with kinking and excessive forces, may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury.¿ ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ no further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebx2245 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
It was reported that during insertion of a picc, the guidewire broke and was found in the subclavian vein.The patient was taken to surgery and the wire was removed by a vascular surgeon.It was stated the wire was about 3¿ in length.It was later reported that the nurse thought it may be from an old picc placement.

• 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: 7259639
• Report Number: 3006260740-2018-00167
• Device Sequence Number: 16433793
• Product Code: LJS
• UDI-Device Identifier: 00801741035609
• UDI-Public: (01)00801741035609
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018
• Report Date (Section F): 01/23/2018

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: 9194108D
• Device Lot Number: REBX2245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 04/30/2018
• 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
• Date Report Sent to FDA: 01/23/2018