MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1385108D3
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a burred guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was one 0.018¿ x 50cm nitinol guidewire.The sample was received in its plastic hoop.Usage residues were observed in the coil region.Slight curved shape memory was observed in the coil region.The proximal end of the coil wire was peeled away from the core wire and protruded from the wire shaft.Microscopic inspection of the wire confirmed that coil wire was peeled away from the core wire at the coil/core transition.The reported guidewire roughness was caused by the dislocation of the coil wire at the transition; however, the cause of the dislocation was not identified.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include wire manipulation prior to or during attempted use.A lot history review (lhr) of reez3387 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported guidewire got hung up on removal-customer states that it feels like there's a burr in the wire.No other information was provided.06/24/2021: the proximal end of the coil wire was peeled away from the core wire and protruded from the wire shaft.

• Brand Name: POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT
• 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: 12184332
• Report Number: 3006260740-2021-02821
• Device Sequence Number: 4425034
• Product Code: LJS
• UDI-Device Identifier: 00801741154966
• UDI-Public: (01)00801741154966
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: S1385108D3
• Device Catalogue Number: S1385108D3
• Device Lot Number: REEZ3387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/16/2021
• 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