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)
Date of Event	10/11/2019
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 first device.
Additional 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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that the sheath was bunching during insertion was confirmed and the damage appeared to be associated with a supplier related issue.One 4fr d/l powerpicc provena was returned for investigation with a 4.5fr galt introducer.Damage was observed along a portion of the distal edge of the introducer sheath.The sheath material was pushed inwards at two points at the distal tip of the sheath tip.The edge at the distal end of the sheath did not exhibit a formed transition.The blunt edge may have contributed to the deformation that occurred during insertion.The manufacturing facility was notified of this complaint.Reynosa evaluation complaint due to ¿bunch/shredding introducer sheath¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual, microscopic visual performed at vad lab it was concluded that the gray distal end sheath was found to be damaged on its radius tip causing difficulty to advance into the patient while using.This kind of defect could be caused during the forming sheath tip process at supplier facility.Therefore, the cause of this condition is supplier related.An incident report was issued to notify our supplier about this issue.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.

• 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: 9288047
• Report Number: 3006260740-2019-03493
• Device Sequence Number: 1671159
• 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,Followup
• Report Date (Section B): 02/11/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR