MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER W/ SHERLOCK 3CG TPS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged microintroducer was confirmed, but the exact cause could not be determined.One 4.5fr x 7cm microintroducer was returned for investigation.The returned sample resembled the introducer in the photograph that was provided for investigation.The dilator and sheath appeared curved due to slight bends along the length of the dilator and sheath.The sheath length and dilator length were within specification.The outside diameter of the dilator was also within specification.A microscopic examination a 0.5mm longitudinal split at the distal tip of the sheath.While the split at the distal end of the sheath may have been a contributing factor in the reported event, it could not be determined if the split existed prior to use or was an effect of the difficult insertion.A review of the manufacturing records showed no findings that indicated damage associated with the manufacturing process.Although the complaint was confirmed, the investigation did not point to a specific root cause.A lot history review (lhr) of redy0810 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "could not advance tried double dilating but still could not advance.Tried double dilating second time and bent to pieces.It bent 3 different places.Got a microintroducer kit out and it went in fine." on 8/03/2021 - the returned sample exhibited slight bends and a split introducer and sheath.What type of catheter securement was utilized: statlock.

• Brand Name: POWERPICC SOLO2 CATHETER W/ 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: 12370847
• Report Number: 3006260740-2021-03523
• Device Sequence Number: 4115305
• Product Code: LJS
• UDI-Device Identifier: 00801741155093
• UDI-Public: (01)00801741155093
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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: 1194108D4
• Device Lot Number: REDY0810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/26/2021
• 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