MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2019
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 redn3390 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "the inserter went to bend the wire outside of the stylet and it broke off.".
Additional Manufacturer Narrative
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 guidewire is confirmed; however, the exact cause is unknown.One 0.018 in.Nitinol guidewire was returned for evaluation.An initial visual observation showed the guidewire was returned in two segments and was measured to be broken approximately 2.5 cm distal to the proximal end of the guidewire.The guidewire leading up to the distal side of the break was noticeably curved; however, the guidewire leading up to the break on the proximal side was observed to be straight.Use residue was observed throughout both segments of the returned sample.The guidewire was bent multiple times at another location near the proximal end as well as near the break on the distal segment and was found to bend easily without breaking at both locations.A microscopic observation revealed the surface of the break was flat and granular in texture.The surface of the guidewire leading up to the break appeared to be slightly deformed and had a sort of wrinkled pattern, especially on the proximal side of the break.One edge of the break on both break surfaces was observed to have a scalloped pattern with depressions in the surface of the guidewire at the break site.Insufficient evidence was observed to determine the exact cause of the reported event.A lot history review (lhr) of redn3390 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "the inserter went to bend the wire outside of the stylet and it broke off.".

• Brand Name: POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 8818224
• Report Number: 3006260740-2019-02120
• Device Sequence Number: 3027272
• Product Code: LJS
• UDI-Device Identifier: 00801741141751
• UDI-Public: (01)00801741141751
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: CK000766
• Device Lot Number: REDN3390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1