MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROVPPSOLO 4FDL MBP; 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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redx1891 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "nitinol wire broken in half prior to pull from sleeve".
Event or Problem Description
It was reported "nitinol wire broken in half prior to pull from sleeve".
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 guidewire is confirmed; however, the exact cause is unknown.One 0.018 in.Nitinol guidewire and one dilator were returned for evaluation.An initial visual observation showed the guidewire was returned in two segments.The nitinol core wire of the guidewire was observed to be broken approximately 6.6 cm distal to the proximal end.The core wire was observed to be curved leading up to the break site, especially on the proximal side of the break.Use residue was observed on the returned samples.A microscopic observation revealed the break sites in the core wire of the guidewire were mostly flat with uneven edges and a granular surface texture.The inner edge of the distal tip of the dilator was observed to be damaged.While the exact cause of the break in the guidewire could not be determined from the evidence observed on the returned samples, possible contributing factors include instrument damage, material fatigue, and embrittlement of the guidewire material.Reynosa evaluation complaint due to ¿nitinol wire broken in half¿ was confirmed but the exact cause is unknown.According with the photo evaluation performed at reynosa facility and gross visual, microscopical visual performed at vad lab the following was concluded: the guidewire was found to be broken in two segments.Damage during the manufacturing process may be a potential root cause/contributor to the observed guidewire damage.However, no findings from the dhr review indicated a manufacturing/processing related event.Possible contributions factors: risks of damage during packaging, clinical procedure, handling or use etc.Therefore, as the definitive root cause of this damage could not be determined the cause of this condition remains unknown.A lot history review (lhr) of redx1891 showed no other similar product complaint(s) from this lot number.

• Brand Name: DOT PROVPPSOLO 4FDL MBP
• 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: 9856592
• Report Number: 3006260740-2020-00895
• Device Sequence Number: 14106060
• Product Code: LJS
• UDI-Device Identifier: 00801741154799
• UDI-Public: (01)00801741154799
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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): 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: S1294108D1
• Device Lot Number: REDX1891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1