MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT,4FR POWERMIDLINE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recx3549 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported there was an issue with the microintroducer.No other information as provided at this time.On 02/19/2019: it was reported that when the introducer was attempted to be placed, the grey sheath bunched up.Pt did end up with a superficial thrombus in the vessel.A new kit was opened to obtain another introducer.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency 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 damaged introducer sheath is confirmed and was determined to be use related.One 4.5 fr microintroducer/dilator assembly was returned for evaluation.An initial visual observation showed use residue on and within the sample.The distal portion of the dilator shaft was observed to be slightly curved.Ridges were observed in the material of the introducer sheath and the distal tip of sheath was observed to be damaged.A microscopic observation revealed the tip of the introducer sheath was damaged on one side and appeared to have been pulled and crumpled inward.Some wrinkling of the material was observed next to the two observed ridges and just proximal to the damage observed in the distal tip of the sheath.The characteristics of the damage observed on the returned introducer sheath are typical of damage caused by difficulty advancing an introducer/dilator into a vessel, which can result from too small of an incision, a steep insertion angle, and/or excessive insertion force.The product ifu states: ¿advance the small sheath and dilator together as a unit over the guidewire, using a slight rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.¿ an examination of the returned sample revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of recx3549 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported there was an issue with the microintroducer.No other information as provided at this time.(b)(6) 2019: it was reported that when the introducer was attempted to be placed, the grey sheath bunched up.Pt did end up with a superficial thrombus in the vessel.A new kit was opened to obtain another introducer.

• Brand Name: DOT,4FR POWERMIDLINE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8418345
• MDR Text Key: 138756504
• Report Number: 3006260740-2019-00557
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: RECX3549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Event Location: Hospital
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention