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

Model Number N/A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/07/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebw0774 showed nine other similar product complaint(s) from this lot number.

Event Description

It was reported that burrs were found at the tail end of the mst when it was being flushed before insertion, making the catheter fail to cross introducer sheath.It was replaced with a new mst kit, and the insertion procedure was completed.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, 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.Guidewire in a plastic hoop was returned for evaluation.An initial visual observation showed no obvious evidence of use on the returned sample.The core wire of the guidewire appeared to be intact during tactile evaluation.A microscopic observation revealed the most distal coil of the guidewire was bent and disjointed but connected to the weld tip.Both weld tips were observed to be present and intact.No evidence was observed which suggested a root cause to the event.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 burrs were found at the tail end of the mst when it was being flushed before insertion, making the catheter fail to cross introducer sheath.It was replaced with a new mst kit, and the insertion procedure was completed.

• 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
• MDR Report Key: 8570079
• MDR Text Key: 143821379
• Report Number: 3006260740-2019-01232
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741074530
• UDI-Public: (01)00801741074530
• Combination Product (y/n): N
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 0668945
• Device Lot Number: REBW0774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Event Location: Hospital
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1