MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC FT CATHETER WITH SHERLOCK 3CG TPS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reez1029 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported attempted procedure and was unable to advance, was pulled without incident and was noted that the magnet wire broke in multiple pieces.Did event occur during placement, during removal, or after removal? during insertion was a new device placed? yes.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet is confirmed; however, the exact cause is unknown.One 5 fr dual lumen powerpicc ft with a 3cg stylet inserted into the red lumen through a t-lock was returned for evaluation.An initial visual observation showed some use residue on the returned sample.The distal end of the stylet was observed to be protruding from the distal end of the catheter and was observed be broken into two pieces approximately 4.2 cm proximal to its distal tip.The polyimide tubing of the distal stylet segment was also found to be broken.Multiple bends and kinks were observed in the returned stylet segments.The epoxy tip of the stylet was observed to be returned.A microscopic observation revealed the breaks in the polyimide tubing were uneven with a rough surface texture and plastic deformation.Many kinks were observed in the polyimide tubing and were each found to be between magnet interfaces.Five of the magnets within the distal stylet segment were observed to be broken.The observed fracture features were indicative of catheter and/or stylet kinking, which likely occurred during the insertion process.However, the exact circumstances providing for that type of event were ultimately unknown.
Event or Problem Description
It was reported attempted procedure and was unable to advance, was pulled without incident and was noted that the magnet wire broke in multiple pieces.Did event occur during placement, during removal, or after removal? during insertion was a new device placed? yes.

• Brand Name: POWERPICC FT CATHETER WITH SHERLOCK 3CG TPS
• 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: 11938983
• Report Number: 3006260740-2021-02179
• Device Sequence Number: 3755128
• Product Code: LJS
• UDI-Device Identifier: 00801741034572
• UDI-Public: (01)00801741034572
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 1275108FD
• Device Lot Number: REEZ1029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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: 82 YR