MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MEX BARRIER PLUS KIT; 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	03/28/2022
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 refx5409 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "while attempting to insert the introducer/dilator, i met an unusual amount of resistance.I retracted the introducer/dilator and noted a defect in the gray portion of the device - where it meets the white tip.".
Event or Problem Description
It was reported via medwatch " while attempting to insert the introducer/dilator, i met an unusual amount of resistance.I retracted the introducer/dilator and noted a defect in the gray portion of the device - where it meets the white tip." add info rcvd 07/21/2022: was the product used on a patient? yes.Was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.No.
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, 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 difficult insertion is confirmed.One 5 fr x 7 cm microez microintroducer was returned for evaluation.The product sticker label indicated lot: refx5409.The dilator was returned wtihin the sheath, and the sheath had not been peeled.Bunching of the sheath tip was also noted.Microscopic observation of the sheath tip revealed the material to be compressed and bunched inwards.Evidence of a sheath tip taper was noted.The damage and deformation observed is consistent with damage caused by advancement against resistance.The product instructions for use (ifu) contains information that may have prevented the reported issue.The ifu states, ¿advance the microintroducer assembly over the guidewire.Using a twisting motion, advance the assembly into the vessel.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.Verify institutional guidelines concerning the use of a safety scalpel prior to making incision." since evidence of a difficult insertion was observed, the complaint is confirmed.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported via medwatch " while attempting to insert the introducer/dilator, i met an unusual amount of resistance.I retracted the introducer/dilator and noted a defect in the gray portion of the device - where it meets the white tip." add info rcvd 07/21/2022: ¿ was the product used on a patient? yes ¿was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.No.

• Brand Name: POWERPICC PROVENA SOLO 5F TL MEX 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14876111
• Report Number: 3006260740-2022-02484
• Device Sequence Number: 12030455
• Product Code: LJS
• UDI-Device Identifier: 00801741155123
• UDI-Public: (01)00801741155123
• 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
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2022

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: S1395108D4
• Device Lot Number: REFX5409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 07/21/2022; 08/19/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/29/2022; 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Male