MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV SP 4F DL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redq1475 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redq1475) have been reported from the same facility.
Event or Problem Description
Facility reported, "we tried the way we have been practicing for a while now which i believe is best practice but taking the inside of the introducer and sliding it over the wire to stretch it out enough to hopefully not have to make a nick but the introducer bunches up and starts to shred with minimal pressure applied.Even with nicks we have been most of the time unable to even get this introducer in and having to drop a better introducer like the galt." it was reported that two introducers have bunched up and shredded.This report addresses the second device.

• Brand Name: DOT PROV SP 4F DL MAX
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9288053
• Report Number: 3006260740-2019-03494
• Device Sequence Number: 19445128
• Product Code: LJS
• UDI-Device Identifier: 00801741134166
• UDI-Public: (01)00801741134166
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S1274108PD
• Device Lot Number: REDQ1475
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1