MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PA INTRODUCER 4.5F X 5CM; INTRODUCER, CATHETER

Model Number N/A

Device Problem Defective Component (2292)

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

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that resistance was felt and the sheath introducer was difficult to insert because the position of the coil wire of the guidewire was misaligned.There was no reported patient injury.

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 lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed; however, the exact cause is unknown.One 0.018 in.Stainless steel guidewire in a plastic hoop was returned for evaluation.An initial visual observation showed use residue on the returned sample.The proximal tip of the guidewire was observed to be damaged.A microscopic observation revealed several of the most distal coils of the guidewire were bent and disjointed but connected to the weld tip.Both weld tips were observed to be present and intact.While the exact cause of the damage observed in the returned guidewire is unknown, possible causes include damage during manufacturing, packaging, handling, or use.

Event Description

It was reported that resistance was felt and the sheath introducer was difficult to insert because the position of the coil wire of the guidewire was misaligned.There was no reported patient injury.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PA INTRODUCER 4.5F X 5CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12245726
• MDR Text Key: 264079003
• Report Number: 3006260740-2021-02986
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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: 0668945J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other