MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM; INTRODUCER, CATHETER

Catalog Number 0668945

Device Problem Scratched Material (3020)

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

Event Date 06/26/2018

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 evaluate.Results are expected soon.A lot history review (lhr) of reby2024 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the guide wire could not be pulled out, and the tip of the guide wire was barbed.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend 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 barbed guidewire was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 4.5fr x 5cm microintroducer kit.The kit components appeared free of obvious usage residues.The guidewire was received in its plastic hoop.Resistance was experienced when attempting to withdraw the guidewire from the hoop.The guidewire was successfully withdrawn from the proximal side of the hoop.Tactile inspection of the sample revealed a misaligned coil near the proximal weld tip.Microscopic inspection of the proximal end of the guidewire confirmed that the proximal most coil was deformed and misaligned.The grind pattern on the coil was unremarkable.No obvious mechanical damage was observed on or around the misaligned coil.The lack of grind pattern irregularity suggested that the coil misalignment occurred following the grinding process.The lack of mechanical damage, deformation and usage residues suggested that the coil misalignment occurred prior to attempted use, likely during the manufacturing process.A quality alert notification, regarding this event, has been sent to the supplier.A lot history review (lhr) of reby2024 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the guide wire could not be pulled out, and the tip of the guide wire was barbed.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM
• Type of Device: INTRODUCER, 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7708505
• MDR Text Key: 114846010
• Report Number: 3006260740-2018-01785
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741074530
• UDI-Public: (01)00801741074530
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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 Catalogue Number: 0668945
• Device Lot Number: REBY2024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/21/2018
• Supplement Dates Manufacturer Received: 09/04/2018
• Supplement Dates FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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