MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO HF CATHETER W/SHERLOCK 3CG TPS STYLET 5F MBT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kink in the distal end of the stylet was confirmed but the cause is unknown.The product returned for evaluation was a 3cg stylet.The stylet was kinked 1.1¿ proximal of the t-lock assembly.The stylet was also kinked 5.7¿, 13.3¿, and 15.3¿ distal of the funnel connector.Kinking was also noticed near the distal end of the stylet, in the magnetic region.The kinks were located 0.3¿ and 0.4¿ from the distal end of the stylet.Microscopic examination of the distal end of the stylet revealed no breaks or fractures within the magnets.The polyimide tubing was compressed between the internal magnets.The epoxy tip was intact and appeared undamaged.The outer diameter of the stylet, both along the core wire and within the magnetic region, met the device specifications.A cross section of the polyimide tubing was taken in a non-damaged section of the wire and the wall thickness was measured.The wall thickness of the polyimide tubing met the device specifications.The exact cause of the kinks in the stylet could not be determined from evaluation of the sample.Possible contributing factors could include advancement/retraction against resistance, stylet kinked during manipulation, and extension of stylet tip past the distal end of the catheter during insertion.A lot history review (lhr) of reew4349 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported ¿stylet wire came out bent at about 1 cm from tip.Picc was placed successfully.I did have to reposition arm in order to get the picc to advance past the axilla.¿ add info rcvd 02/09/2021: placement info: placed in l brachial was there patient harm reported?: no.(b)(6) 2021- the returned wire is kinked.

• Brand Name: POWERPICC SOLO HF CATHETER W/SHERLOCK 3CG TPS STYLET 5F MBT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12013440
• Report Number: 3006260740-2021-02304
• Device Sequence Number: 19632509
• Product Code: LJS
• UDI-Device Identifier: 00801741034725
• UDI-Public: (01)00801741034725
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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: N/A
• Device Catalogue Number: 1395108QD
• Device Lot Number: REEW4349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/16/2021
• 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
• Patient Age: 67 YR