MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/05/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regn0485 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the customer "two days ago one of our team members was placing a picc.He consistently performs a dermatotome on all of his patients.This said, he attempted to insert the introducer.He was feeling unusual resistance.So, he pulled out the introducer which resulted in immediate heavy bleeding from the site.He did not keep the device.Inserted (b)(6) 2022.

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 batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint a damaged introducer sheath was confirmed but the cause is unknown.A single photograph of a distal section of a microintroducer/dilator/sheath was returned for evaluation.The distal end of the sheath appeared jagged in one area, with the material bent away from the dilator.Per the event description, unusual resistance was felt while attempting to inset the introducer.It is likely that the difficult insertion contributed to the visible damage on the sheath.However, it is not known if additional unknown factors contributed to this event.Examination of the distal end of the device, microscopic observation, tactile evaluation, and dimensional analysis could not be conducted without the physical sample.Therefore, the exact root cause of the damage to the sheath could not be determined.Possible contributing factors could include poor transition of the introducer sheath to the dilator, advancement against resistance, or damage to the sheath prior to use.Sheath damage can be minimized by simultaneously advancing the sheath and dilator as a single unit using a rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported by the customer "two days ago one of our team members was placing a picc.He consistently performs a dermatotomy on all of his patients.This said, he attempted to insert the introducer.He was feeling unusual resistance.So, he pulled out the introducer which resulted in immediate heavy bleeding from the site.He did not keep the device.Inserted (b)(6) 2022.

• Brand Name: POWERPICC PROVENA SOLO
• Type of Device: 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15136109
• MDR Text Key: 303325793
• Report Number: 3006260740-2022-02963
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CK000931A
• Device Lot Number: REGN0485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2022
• 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 Outcome(s): Other