MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/BIOPATCH; 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	04/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.During functional testing the reported problem was unable to be reproduced.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The reported condition "not occluding at the correct pressure" was not verified.Troubleshooting the device revealed no hardware/software abnormalities that would induce the reported allegation.No correction is required.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported "unable to advance microintroducer inside the vein, shearing on the "gray" part of the microintroducer." no other information was provided.
Event or Problem Description
It was reported "unable to advance microintroducer inside the vein, shearing on the "gray" part of the microintroducer." no other information was provided.
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 3.5 fr microez microintroducer was returned for evaluation.The product sticker label indicated lot: refy3773.The sheath had not been peeled.The sheath was observed to be bent at the proximal end extending from the peelable tabs.Bunching of the sheath tip was also noted.Microscopic observation of the sheath tip revealed the material to be compressed and bunched inwards.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 prevent 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 inserted was observed, the complaint is confirmed.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/BIOPATCH
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14458232
• Report Number: 3006260740-2022-01842
• Device Sequence Number: 14578762
• Product Code: LJS
• UDI-Device Identifier: 00801741155185
• UDI-Public: (01)00801741155185
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: S1193108D5
• Device Lot Number: REFX2677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/08/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 91 KG