MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA CATHETER W/SOLO VALVE TECHNOLOGY AND SHERLOCK 3CG TPS 5 FR T/L; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number S1395108D

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of reay0332 showed four other similar product complaint(s) from this lot number.The complaints for this lot number (reay0332) have been reported from the same us facility.

Event Description

It was reported to the sales rep that the nurse noticed a raised ridge on the shaft of the introducer after difficulty was experienced during the insertion.No patient injury was reported.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged introducer was confirmed and determined to be manufacturing related.One 5 fr microintroducer was returned for investigation.The sheath was positioned over the vessel dilator.The sheath was buckled 1.9cm from the distal tip of the sheath.The distal tip of the sheath and the dilator tip revealed no deformation.When compared to an unused non-complaint sample, the edge at the distal end of the returned sheath revealed a more abrupt transition, which appeared to be a contributing factor in the buckled sheath.This issue was addressed in (b)(4) and re-capa-(b)(4).The product 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.¿ (b)(4) evaluation: the complaint per ¿raised ridge on the shaft of the introducer and difficulty of insertion" ".Based on the visual evaluation of the photo and according to the process that is carried out in the manufacturing line, this kind of damage can be produced during the rf operation during tip forming.Due to this the complaint is confirmed as manufacturing related.A lot history review (lhr) of reay0332 showed four other similar product complaint(s) from this lot number.The complaints for this lot number (reay0332) have been reported from the same us facility.

Event Description

It was reported to the sales rep that the nurse noticed a raised ridge on the shaft of the introducer after difficulty was experienced during the insertion.No patient injury was reported.

• Brand Name: POWERPICC PROVENA CATHETER W/SOLO VALVE TECHNOLOGY AND SHERLOCK 3CG TPS 5 FR T/L
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7123682
• MDR Text Key: 95484929
• Report Number: 3006260740-2017-02248
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741112751
• UDI-Public: (01)00801741112751
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S1395108D
• Device Catalogue Number: S1395108D
• Device Lot Number: REAY0332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 133