MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F; INTRODUCER, CATHETER

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

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 damaged guidewire is confirmed but the exact cause is unknown.One guidewire within its hoop, one microez microintroducer, and two needles were returned for evaluation.The tip of the guidewire was observed to have a slight deformation near the distal end.Microscopic observation of the deformed revealed the coils to be misaligned near the distal weld tip.Dried, red residue appears to be present on the device.The deformed coils appear to be compressed and twisted out of alignment.Based on the information provided, possible contributing factors include instrument damage and damage during handling.Since the guidewire was observed to be damaged, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of redu4200 showed two other similar product complaint(s) from this lot number.

Event Description

It was reported that protruding burrs were found with the tip of the guide wire, which resulted in the failure of the guide wire to insert into the introducer sheath.In addition, multiple mst introducer sheaths were found naturally bent after their packages were opened.On (b)(6) 2021- the coils of the returned guidewire are misaligned near the distal weld tip.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F
• Type of Device: INTRODUCER, CATHETER
• 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: 12523490
• MDR Text Key: 273081783
• Report Number: 3006260740-2021-03961
• Device Sequence Number: 1
• Product Code: DYB
• 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
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0668945
• Device Lot Number: REDU4200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• 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