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

Model Number N/A

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/26/2019

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 recu2157 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the physician found that the guidewire had been kinked when a kit was opened.It was further reported that the catheter was placed successfully.There was no reported patient injury.

Manufacturer Narrative

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, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the guidewire being kinked prior to use could not be confirmed as evidence of use was observed on the returned sample.One 35 cm guidewire within the hoop was returned for investigation.A kink was observed 4.1 cm from the distal end of the wire that was extending outside of the hoop.The guidewire was removed.Two additional kinks were observed 13 and 13.5 cm from the distal end.Use residue was observed around the sample.Microscopic observation of the guidewire kinks revealed the coils to be misaligned.Based on the condition of the returned sample, possible contributing factors include damage during handling and advancement against resistance.Since multiple kinks were present on the returned sample, the complaint of a guidewire kink is confirmed, cause unknown.A lot history review (lhr) of recu2157 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the physician found that the guidewire had been kinked when a kit was opened.It was further reported that the catheter was placed successfully.There was no reported patient injury.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM -JAPA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8478951
• MDR Text Key: 140801351
• Report Number: 3006260740-2019-00759
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• 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
• Device Lot Number: RECU2157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Event Location: Hospital
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1